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Respiratory failure requiring endotracheal intubation occurs in as many as 40% of critically ill patients. Procedural complications including failed attempts at intubation, esophageal intubation, arterial oxygen desaturation, aspiration, hypotension, cardiac arrest, and death are common in this setting. While there are many important components of successful airway management in critical illness, the maintenance of adequate arterial hemoglobin saturation from procedure initiation until endotracheal tube placement is paramount as desaturation is the most common factor associated with peri-intubation cardiac arrest and death. Interventions that either shorten the duration of time required for tube placement or prolong the period before desaturation may be effective in improving outcome. The high rate of complications and the lack of existing evidence regarding the efficacy of current airway management techniques in shortening the time to airway establishment or prolonging the time to desaturation mandates further investigation. The primary hypothesis is that video laryngoscopy will be superior to direct laryngoscopy in successful first attempt at endotracheal intubation (defined by confirmed placement of an endotracheal tube in the trachea during first laryngoscopy attempt) of medical ICU patients by Pulmonary/Critical Care Medicine fellows after controlling for the operator's past number of procedures with the equipment used. Also, the investigators hypothesize that the provision of apneic oxygenation during the endotracheal intubation procedure (defined as a nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure) will result in a higher arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death) compared to no apneic oxygenation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VL and AO | Active Comparator | Video laryngoscopy and apneic oxygenation |
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| DL and AO | Active Comparator | Direct Laryngoscopy and apneic oxygenation |
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| VL and no AO | Active Comparator | Video Laryngoscopy and no apneic oxygenation |
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| DL and no AO | Active Comparator | Direct Laryngoscopy and no apneic oxygenation |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Video Laryngoscopy | Device |
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| Apneic Oxygenation |
| Measure | Description | Time Frame |
|---|---|---|
| Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator's Past Number of Procedures With the Equipment Used. | The primary outcome for the video laryngoscopy compared with direct laryngoscopy arm of the study will be the successful first attempt at endotracheal intubation (defined by confirmed placement of an endotracheal tube in the trachea during first laryngoscopy attempt) after controlling for the operator's past number of procedures with the equipment used. | 1 hour |
| Arterial Oxygen Saturation Nadir (Defined as Lowest Noninvasive Oxygenation Saturation Value Observed Between the Administration of Sedation and/or Neuromuscular Blockade and 2 Minutes After Successfully Secured Airway or Death). | The primary outcome for the apneic oxygenation arm of the study is arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death). | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Procedure-related Mortality | Death within 1 hour of beginning the procedure | 1 hour |
| ICU-mortality | Death from any cause in the ICU and at anytime after the procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Matthew W Semler, MD | Vanderbilt University | Principal Investigator |
| Todd W Rice, MD, MSc | Vanderbilt University | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26426458 | Derived | Semler MW, Janz DR, Lentz RJ, Matthews DT, Norman BC, Assad TR, Keriwala RD, Ferrell BA, Noto MJ, McKown AC, Kocurek EG, Warren MA, Huerta LE, Rice TW; FELLOW Investigators; Pragmatic Critical Care Research Group. Randomized Trial of Apneic Oxygenation during Endotracheal Intubation of the Critically Ill. Am J Respir Crit Care Med. 2016 Feb 1;193(3):273-80. doi: 10.1164/rccm.201507-1294OC. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Video Laryngoscopy and No Apneic Oxygenation | Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope. No Apneic Oxygenation |
| FG001 | Direct Laryngoscopy and Apneic Oxygenation |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Device |
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| Direct Laryngoscopy | Device |
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| No Apneic Oxygenation | Device |
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| 28 days |
| Adjusted Lowest Arterial Oxygen Saturation During Procedure | Arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death) adjusted for arterial oxygen saturation at the time of administering intubation drugs. | 1 hour |
| Ventilator-free Days | Number of days alive and free of mechanical ventilation after endotracheal intubation | 28 days |
| Number of Esophageal Intubations Per Group | Number of esophageal intubations Per Study Group | 1 hour |
| Grade View of the Glottis | Best Cormack-Lehane grade view of the glottis (grade 1-4) on first laryngoscopy attempt. Higher grades on the 1-4 scale indicate worse glottic views. | 1 hour |
Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope. Apneic Oxygenation |
| FG002 | Video Laryngoscopy and Apneic Oxygenation | A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure Video Laryngoscopy |
| FG003 | Direct Laryngoscopy and No Apneic Oxygenation | No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure. Direct Laryngoscopy |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Video Laryngoscopy and Apneic Oxygenation | Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope. and A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure |
| BG001 | Direct Laryngoscopy and Apneic Oxygenation | Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope. and A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure |
| BG002 | Video Laryngoscopy and no Apneic Oxygenation | Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope. and No apneic oxygenation |
| BG003 | Direct Laryngoscopy and No Apneic Oxygenation | Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope. and No apneic oxygenation |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Body Mass Index | Mean | Standard Deviation | kg/m^2 |
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| Acute Physiology and Chronic Health Evaluation II Score | range of scale is minimum 0 - maximum 100 lower values describe less acute/chronic illness and more likely to survive higher values describe more acute/chronic illness and less likely to survive | Mean | Standard Deviation | units on a scale |
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| 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 | Successful First Attempt at Endotracheal Intubation (Defined by Confirmed Placement of an Endotracheal Tube in the Trachea During First Laryngoscopy Attempt) After Controlling for the Operator's Past Number of Procedures With the Equipment Used. | The primary outcome for the video laryngoscopy compared with direct laryngoscopy arm of the study will be the successful first attempt at endotracheal intubation (defined by confirmed placement of an endotracheal tube in the trachea during first laryngoscopy attempt) after controlling for the operator's past number of procedures with the equipment used. | Posted | Number | participants | 1 hour |
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| Primary | Arterial Oxygen Saturation Nadir (Defined as Lowest Noninvasive Oxygenation Saturation Value Observed Between the Administration of Sedation and/or Neuromuscular Blockade and 2 Minutes After Successfully Secured Airway or Death). | The primary outcome for the apneic oxygenation arm of the study is arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death). | Posted | Median | Inter-Quartile Range | percent arterial oxygen saturation | 1 hour |
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| Secondary | Procedure-related Mortality | Death within 1 hour of beginning the procedure | Posted | Count of Participants | Participants | 1 hour |
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| Secondary | ICU-mortality | Death from any cause in the ICU and at anytime after the procedure | Posted | Count of Participants | Participants | 28 days |
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| Secondary | Adjusted Lowest Arterial Oxygen Saturation During Procedure | Arterial oxygen saturation nadir (defined as lowest noninvasive oxygenation saturation value observed between the administration of sedation and/or neuromuscular blockade and 2 minutes after successfully secured airway or death) adjusted for arterial oxygen saturation at the time of administering intubation drugs. | Posted | Mean | Standard Deviation | PERCENT SATURATION | 1 hour |
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| Secondary | Ventilator-free Days | Number of days alive and free of mechanical ventilation after endotracheal intubation | Posted | Mean | Standard Deviation | DAYS | 28 days |
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| Secondary | Number of Esophageal Intubations Per Group | Number of esophageal intubations Per Study Group | Posted | Number | number of esophageal intubations | 1 hour |
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| Secondary | Grade View of the Glottis | Best Cormack-Lehane grade view of the glottis (grade 1-4) on first laryngoscopy attempt. Higher grades on the 1-4 scale indicate worse glottic views. | Posted | Mean | Standard Deviation | units on a scale | 1 hour |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Video Laryngoscopy | Patients randomized to undergo endotracheal intubation using the operator's choice of McGrath® video laryngoscope, GlideScope® video laryngoscope, or bronchoscope. Apneic Oxygenation No Apneic Oxygenation | 0 | 74 | 0 | 74 | ||
| EG001 | Direct Laryngoscopy | Patients randomized to undergo endotracheal intubation using the operator's choice of a MacIntosh or Miller blade direct laryngoscope. Apneic Oxygenation No Apneic Oxygenation | 0 | 76 | 0 | 76 | ||
| EG002 | Apneic Oxygenation | A nasal cannula with 15 liters per minute of oxygen flow placed prior to sedation or neuromuscular blockade and maintained until after completion of the procedure Video Laryngoscopy Direct Laryngoscopy | 0 | 77 | 0 | 77 | ||
| EG003 | No Apneic Oxygenation | No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure. Video Laryngoscopy Direct Laryngoscopy | 0 | 73 | 0 | 73 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| David Janz, MD, MSc | LSU School of Medicine New Orleans | 504-568-3167 | djanz@lsuhsc.edu |
| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| Male |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| OG003 | No Apneic Oxygenation | No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure. Video Laryngoscopy Direct Laryngoscopy |
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| Direct Laryngoscopy and No Apneic Oxygenation |
No nasal cannula, supplemental oxygen given after sedation or neuromuscular blockade until completion of the procedure. Direct Laryngoscopy |
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