Pragmatic Trial Examining Oxygenation Prior to Intubation | NCT05267652

Status Module

Name	Class
University of Colorado, Denver	OTHER

Oversight Module

Description Module

Detailed Description

BACKGROUND:

Clinicians frequently perform tracheal intubation of critically ill patients in the emergency department (ED) or intensive care unit (ICU). Complications of intubation, including hypoxemia and cardiovascular instability, occur in nearly half of intubations performed in these settings. Preventing complications during tracheal intubation is a key focus of clinical care and airway management research.

HYPOXEMIA DURING INTUBATION OF CRITICALLY ILL PATIENTS:

Life-threatening hypoxemia occurs in 1-in-10 cases of emergency tracheal intubation. Severe hypoxemia during intubation is associated with increased risk of cardiac arrest and death. Severe hypoxemia may be associated with worse outcomes in survivors. For example, neurologic recovery from traumatic brain injury may be worse after hypoxemia due to secondary ischemic insult.

ROLE OF PREOXYGENATION IN PREVENTING HYPOXEMIA DURING INTUBATION:

In current clinical practice, emergency tracheal intubation involves the nearly simultaneous administration of a sedative agent and a neuromuscular blocking agent to optimize the anatomic conditions for intubation. Following medication administration, patients rapidly become hypopneic and then apneic until invasive mechanical ventilation is initiated through the newly-placed endotracheal tube. The oxygen contained in the lungs at the time of neuromuscular blockade (i.e., the patient's functional residual capacity) is the reservoir of oxygen available to the patient's body to prevent hypoxemia and tissue hypoxia during the intubation procedure. For a patient breathing ambient air (i.e., room air), only 21% of the gas in the functional residual capacity is oxygen; 78% is nitrogen. Administering 100% oxygen to a patient prior to induction of anesthesia and tracheal intubation, referred to as "preoxygenation," can replace the nitrogen in the lung with oxygen, increasing up to five-fold the reservoir of oxygen available to the body during the procedure and prolonging the period during which intubation can be performed safely without encountering hypoxemia. In current clinical practice, the two most common methods of providing preoxygenation are:

Non-invasive positive pressure ventilation - a tight-fitting mask connected to either an invasive ventilator or non-invasive mechanical ventilator.
Facemask oxygen - with either a non-rebreather mask or a bag-mask device.

PREOXYGENATION WITH NON-INVASIVE POSITIVE PRESSURE VENTILATION:

Preoxygenation with non-invasive positive pressure ventilation is common during emergency tracheal intubation of critically ill adults in current clinical practice. During preoxygenation with non-invasive positive pressure ventilation, a tight-fitting mask is connected to a machine capable of providing positive pressure ventilation. Non-invasive positive pressure ventilation delivers up to 95-100% oxygen and can be provided by either a conventional invasive mechanical ventilator or a dedicated non-invasive ventilation machine, commonly referred to as a Bilevel Positive Airway Pressure (BiPAP) machine. In addition to providing high concentrations of oxygen, non-invasive positive pressure ventilation increases mean airway pressure and delivers breaths at a set rate during the period of hypopnea/apnea after induction. Because a mechanical ventilator is always required following intubation of a critically ill adult, no specialized equipment is required to use non-invasive positive pressure ventilation for preoxygenation of critically ill adults undergoing tracheal intubation.

PREOXYGENATION WITH FACEMASK OXYGEN:

In current clinical practice, preoxygenation with facemask oxygen is commonly performed using one of the following two types of facemask: [1] a non-rebreather mask or [2] a bag-mask device. Both a types of facemask (a non-rebreather and a compressed bag-mask device) deliver supplemental oxygen without increasing airway pressures or providing assistance with ventilation.

A non-rebreather mask is a type of facemask with a loose-fitting mask that sits over a patient's nose and mouth and is connected to an oxygen reservoir. It delivers at least 15 liters per minute of 100% oxygen, but it may not reliably deliver flows of oxygen greater than 15 liters per minute and may allow entrainment of ambient air. Studies show that the while the oxygen content for healthy and calm volunteers may approach 100%, the oxygen content received by critically ill patients with tachypnea may be as low as 50%. It does not provide positive pressure.
A bag mask device is a type of facemask with a mask that forms a tight seal over the mouth and nose when held in place by the operator, an exhalation port, and a self-inflating bag that serves as a reservoir for oxygen and can be compressed to provide positive pressure ventilation. If the bag of this device is compressed, this device delivers oxygen without providing positive pressure ventilation and can deliver more than 90% oxygen with an ideal mask seal. However, in the setting of emergency intubation leaks may result in the entrainment of ambient air and reduced oxygen delivery.

POTENTIAL ADVANTAGES OF PREOXYGENATION WITH NON-INVASIVE POSITIVE PRESSURE VENTILATION OR PREOXYGENATION WITH FACEMASK OXYGEN:

Preoxygenation with non-invasive positive pressure ventilation has been proposed to offer the following potential advantages compared to preoxygenation with facemask oxygen:

Entrainment of ambient air: The tight-fitting mask used to deliver non-invasive ventilation entrains less ambient air than a non-rebreather or bag-mask device. The higher flow rates of oxygen gas with non-invasive ventilation may also help prevent entrainment of ambient air and increase the fraction of inspired oxygen.
Atelectasis and alveolar recruitment: Preoxygenation and induction of anesthesia rapidly results in the development of atelectasis in both healthy patients and critically ill patients. This atelectasis increases shunt fraction and increases the risk of peri-procedural hypoxia. By delivering positive pressure during both inspiration and expiration, non-invasive ventilation raises mean airway pressure, recruiting alveoli and preventing the development of atelectasis.
Hypopnea and Apnea. Administration of sedation and neuromuscular blocking agents reduces or eliminates spontaneous respiratory effort. This hypoventilation leads to accumulation of alveolar carbon dioxide and reductions in alveolar oxygen, contributing to hypoxemia. Use of non-invasive ventilation before induction and between induction and laryngoscopy provides continuous oxygen to the alveoli, increases the size of breaths taken in the setting of hypopnea, and delivers controlled breaths when patients are apneic.

Preoxygenation with facemask oxygen (via a non-rebreather or compressed bag-mask device) has been proposed to offer the following potential advantages compared with preoxygenation with non-invasive positive pressure ventilation:

Simplicity of use: Preoxygenation with facemask oxygen (using either a non-rebreather or compressed bag-mask device) is simpler to set up than non-invasive positive pressure ventilation.
Low risk of gastric insufflation: Although no clinical evidence exist to suggest that preoxygenation with non-invasive positive pressure ventilation increases the risk of gastric insufflation or aspiration of gastric contents, use of facemask oxygen (without any positive pressure) avoids this hypothetical concern.

PRIOR EVIDENCE FROM CLINICAL TRIALS:

Two small clinical trials have compared preoxygenation with non-invasive ventilation to preoxygenation with facemask oxygen during the tracheal intubation of critically ill adults. The first trial compared non-invasive ventilation to a facemask among 53 critically ill ICU patients in two hospitals and found that non-invasive ventilation increased the lowest oxygen saturation (93% vs. 81%, p<0.001) with no difference in incidence of aspiration (6% vs. 8%). The second trial compared non-invasive ventilation to a facemask oxygen with regard to severity of illness in the 7 days after intubation among 201 critically ill ICU patients. This trial found no significant difference in the severity of illness between groups and no significant difference in the rate of severe hypoxemia (18.4% vs 27.7%, p=0.10). This trial did not have adequate statistical power to detect clinically important differences between groups in the risk of hypoxemia. No large, multicenter trials have compared preoxygenation with non-invasive positive pressure ventilation to preoxygenation with facemask oxygen for critically ill adults undergoing tracheal intubation. Based on the available data from these small randomized clinical trials, preoxygenation with non-invasive positive pressure ventilation and preoxygenation with facemask oxygen both represent acceptable approaches to emergency tracheal intubation. Both approaches are considered standard-of-care and are used commonly in current clinical practice.

RATIONALE FOR A LARGE MULTICENTER TRIAL OF PREOXYGENATION:

Because of the imperative to optimize emergency tracheal intubation in clinical care, the common use of both preoxygenation with non-invasive positive pressure ventilation and preoxygenation with facemask oxygen in current clinical practice, and the lack of existing data from randomized trials to definitively inform whether preoxygenation strategy effects the rate of hypoxemia, examining the approach to preoxygenation during emergency tracheal intubation represents an urgent research priority. To address this knowledge gap, the investigators propose to conduct a large, multicenter, randomized clinical trial comparing preoxygenation with non-invasive positive pressure ventilation versus preoxygenation with facemask oxygen with regard to hypoxemic during tracheal intubation of critically ill adults in the ED or ICU.

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Preoxygenation with Non-Invasive Positive Pressure Ventilation Group	Active Comparator	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.	Other: Preoxygenation with Non-Invasive Positive Pressure Ventilation
Preoxygenation with Facemask Oxygen Group	Active Comparator	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.	Other: Facemask Oxygen

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Preoxygenation with Non-Invasive Positive Pressure Ventilation	Other	The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of Hypoxemia	A peripheral oxygen saturation < 85% during the interval between induction and 2 minutes after tracheal intubation	from induction to 2 minutes following tracheal intubation

Secondary Outcomes

Measure	Description	Time Frame
Lowest Oxygen Saturation	Lowest oxygen saturation during the interval between induction and 2 minutes after tracheal intubation	from induction to 2 minutes following tracheal intubation

Other Outcomes

Measure	Description	Time Frame
Incidence of Operator-reported Aspiration		from induction to 2 minutes following tracheal intubation
Fraction of Inspired Oxygen at 24 Hours After Induction		24 hours after induction

Eligibility Module

Contacts/Locations Module

Overall Officials

Name	Affiliation	Role
Jonathan D Casey, MD, MSc	Vanderbilt University Medical Center	Principal Investigator
Adit A Ginde, MD, MPH	University of Colorado, Denver	Principal Investigator
Matthew W Semler, MD, MSc	Vanderbilt University Medical Center	Study Director
Kevin W Gibbs, MD	Wake Forest University Health Sciences	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
UAB Hospital		Birmingham	Alabama	35233	United States
University of Colorado Denver

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
38869091	Derived	Gibbs KW, Semler MW, Driver BE, Seitz KP, Stempek SB, Taylor C, Resnick-Ault D, White HD, Gandotra S, Doerschug KC, Mohamed A, Prekker ME, Khan A, Gaillard JP, Andrea L, Aggarwal NR, Brainard JC, Barnett LH, Halliday SJ, Blinder V, Dagan A, Whitson MR, Schauer SG, Walker JE Jr, Barker AB, Palakshappa JA, Muhs A, Wozniak JM, Kramer PJ, Withers C, Ghamande SA, Russell DW, Schwartz A, Moskowitz A, Hansen SJ, Allada G, Goranson JK, Fein DG, Sottile PD, Kelly N, Alwood SM, Long MT, Malhotra R, Shapiro NI, Page DB, Long BJ, Thomas CB, Trent SA, Janz DR, Rice TW, Self WH, Bebarta VS, Lloyd BD, Rhoads J, Womack K, Imhoff B, Ginde AA, Casey JD; PREOXI Investigators and the Pragmatic Critical Care Research Group. Noninvasive Ventilation for Preoxygenation during Emergency Intubation. N Engl J Med. 2024 Jun 20;390(23):2165-2177. doi: 10.1056/NEJMoa2313680. Epub 2024 Jun 13.
36993496

IPD Sharing Statement Module

Results Section

Participant Flow Module

Arm/Group Information

ID	Title	Description
FG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.

Baseline Characteristics Module

Outcome Measures Module

Adverse Events Module

More Info Module

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot_SAP	Yes	Yes	No	Study Protocol and Statistical Analysis Plan	Sep 1, 2023

Arm/Group Information

ID	Title	Description
BG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
BG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.
BG002	Total	Total of all reporting groups

Baseline Measures

Title

Description

Population Description

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Denominator Units Selected

Denominators

Classes

Age, Continuous

Median

Inter-Quartile Range

years

Title

Denominators

Categories

Title	Measurements
	BG00061(47 to 71) BG00161(47 to 70) BG00261(47 to 71)

Sex: Female, Male

Count of Participants

Participants

Title

Denominators

Categories

Title	Measurements
Female	BG000255 BG001260 BG002

Race/Ethnicity, Customized

Count of Participants

Participants

Title

Denominators

Categories

Non-Hispanic White

Title	Measurements
	BG000384 BG001399 BG002

Region of Enrollment

Number

participants

Title

Denominators

Categories

United States

Title	Measurements
	BG000645 BG001656 BG002

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Incidence of Hypoxemia

A peripheral oxygen saturation < 85% during the interval between induction and 2 minutes after tracheal intubation

Posted

Count of Participants

Participants

from induction to 2 minutes following tracheal intubation

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Units	Counts
Participants	OG000624 OG001637

Title

Denominators

Categories

Title	Measurements
	OG00057 OG001118

Secondary

Lowest Oxygen Saturation

Lowest oxygen saturation during the interval between induction and 2 minutes after tracheal intubation

Posted

Median

Inter-Quartile Range

Oxygen Saturation (%)

from induction to 2 minutes following tracheal intubation

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Incidence of Operator-reported Aspiration

Posted

Count of Participants

Participants

from induction to 2 minutes following tracheal intubation

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Fraction of Inspired Oxygen at 24 Hours After Induction

Posted

Median

Inter-Quartile Range

Percentage

24 hours after induction

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Oxygen Saturation at 24 Hours After Induction

Posted

Median

Inter-Quartile Range

Oxygen Saturation (%)

24 hours after induction

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Incidence of Pneumothorax

Radiology report of new pneumothorax on chest x-ray in the 24 hours after induction

Posted

Count of Participants

Participants

from induction to 24 hours after induction

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Incidence of New Infiltrate

Radiology report of new infiltrate on chest imaging in the 24 hours after intubation

Posted

Count of Participants

Participants

from induction to 24 hours after induction

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Incidence of Severe Hypoxemia

Lowest oxygen saturation of <80% between induction and two minutes after tracheal intubation

Posted

Count of Participants

Participants

from induction to 2 minutes following tracheal intubation

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Incidence of Very Severe Hypoxemia

Lowest oxygen saturation of <70% between induction and two minutes after tracheal intubation

Posted

Count of Participants

Participants

from induction to 2 minutes following tracheal intubation

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Oxygen Saturation at Induction

Posted

Median

Inter-Quartile Range

Oxygen Saturation (%)

from enrollment to induction

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Systolic Blood Pressure at Induction

Posted

Median

Inter-Quartile Range

mmHg

from enrollment to induction

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Duration From Induction to Successful Intubation

Posted

Median

Inter-Quartile Range

Seconds

Duration of procedure (minutes)

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Cormack-Lehane Grade of Glottic View on First Attempt

Grade 1: Full view of glottis Grade 2: Partial view of glottis Grade 3: Only epiglottis seen (none of glottis) Grade 4: Neither glottis nor epiglottis seen

Posted

Count of Participants

Participants

Duration of procedure (minutes)

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Incidence of Successful Intubation on the First Attempt

Placement of an endotracheal tube in the trachea with a single insertion of a laryngoscope blade into the mouth and either a single insertion of an endotracheal tube into the mouth or a single insertion of a bougie into the mouth followed by a single insertion of an endotracheal tube into the mouth

Posted

Count of Participants

Participants

Duration of procedure (minutes)

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Number of Laryngoscopy Attempts

Posted

Median

Inter-Quartile Range

attempts

Duration of procedure (minutes)

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Number of Attempts at Passing a Bougie

Posted

Median

Inter-Quartile Range

attempts

Duration of procedure (minutes)

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Number of Attempts at Passing an Endotracheal Tube

Posted

Median

Inter-Quartile Range

attempts

Duration of procedure (minutes)

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Incidence of Cardiovascular Collapse

A composite of one or more of the following between induction and 2 minutes after intubation:

Systolic blood pressure < 65 mmHg
New or increased vasopressor
Cardiac arrest not resulting in death within 1 hour of induction
Cardiac arrest resulting in death within 1 hour of induction

Posted

Count of Participants

Participants

from induction to 2 minutes following tracheal intubation

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

28-day In-hospital Mortality

Posted

Count of Participants

Participants

28 days

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

Ventilator-free Days to 28 Days

Posted

Median

Inter-Quartile Range

Days

28 days

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Other Pre-specified

ICU-free Days to 28 Days

Posted

Median

Inter-Quartile Range

Days

28 days

ID	Title	Description
OG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.
OG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Preoxygenation With Non-Invasive Positive Pressure Ventilation Group	Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation. Preoxygenation with Non-Invasive Positive Pressure Ventilation: The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.	209	645	2	645	0	645
EG001	Preoxygenation With Facemask Oxygen Group	For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians. Facemask Oxygen: The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.	217	656	0	656	0	656

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms