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The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial.
Endotracheal intubation is common in the care of critically ill patients. Procedural complications including hypoxia and hypotension are frequent in urgent and emergent intubation and associated with an increased risk of death. The use of a written, pre-procedure checklist and positioning the patient with the head of the bed elevated have been proposed as interventions capable of preventing complications during non-elective intubation and are used intermittently in routine care -- however neither have been examined in a prospective trial. The investigators propose a randomized trial comparing use of a written checklist versus no written checklist and ramped versus sniffing position for endotracheal intubation of critically ill adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sniffing Position, No Checklist | No Intervention | Patient in the sniffing position without the use of a written checklist | |
| Sniffing Position, Checklist | Active Comparator | Patient in the sniffing position with the use of a written checklist |
|
| Head of Bed Up, No Checklist | Active Comparator | Patient with the head of bed up and without the use of a checklist |
|
| Head of Bed Up, Checklist | Active Comparator | Patient with the head of bed up and with the use of a checklist |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Written Checklist | Procedure | Use of a written checklist pre and peri-intubation |
|
| Measure | Description | Time Frame |
|---|---|---|
| Lowest Arterial Oxygen Saturation (Both positioning and Checklist interventions) | Lowest non-invasively measured arterial oxygen saturation between the time of induction or neuromuscular blockade and two minutes after completion of the airway management procedure | Time of Induction through 2 minutes after successful intubation |
| Lowest Systolic Blood Pressure (Checklist intervention only) | Lowest non-invasively or invasively measured systolic blood pressure between medication administration and 2 minutes following successful placement of an endotracheal tube (in checklist comparison only) | Time of Induction through 2 minutes after successful intubation |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Desaturation | Decrease in oxygen saturation of greater than 3% from induction to lowest oxygen saturation | Time of Induction through 2 minutes after successful intubation |
| Incidence of Hypoxemia |
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Inclusion Criteria:
Airway management events will be included in which:
Exclusion Criteria:
Airway management events will be excluded in which:
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| Name | Affiliation | Role |
|---|---|---|
| Todd W Rice, MD, MSc | Vanderbilt University Medical Center | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama - Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Louisiana State University School of Medicine |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28917549 | Derived | Janz DR, Semler MW, Joffe AM, Casey JD, Lentz RJ, deBoisblanc BP, Khan YA, Santanilla JI, Bentov I, Rice TW; Check-UP Investigators*; Pragmatic Critical Care Research Group. A Multicenter Randomized Trial of a Checklist for Endotracheal Intubation of Critically Ill Adults. Chest. 2018 Apr;153(4):816-824. doi: 10.1016/j.chest.2017.08.1163. Epub 2017 Sep 14. | |
| 28487139 |
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| ID | Term |
|---|---|
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D057189 | Checklist |
| D056888 | Patient Positioning |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Head of Bed Up | Procedure | Raising the patient's head of bed to 25 degrees |
|
|
Defined by lowest oxygen saturation less than 90% and severe hypoxemia as defined by lowest oxygen saturation less than 80%
| Time of Induction through 2 minutes after successful intubation |
| Change in Saturation | Change in oxygen saturation from baseline to lowest oxygen saturation | Time of Induction through 2 minutes after successful intubation |
| Grade of First Glottic View | Cormack-Lehane grade of view on first intubation attempt | Time of Induction through 2 minutes after successful intubation |
| First Pass Success | Placement of an endotracheal tube in the trachea after the first insertion of the laryngoscope into the oral cavity without the use of any other devices | Time of Induction through 2 minutes after successful intubation |
| Number of Intubation Attempts | Number of attempts required for successful tube placement | Time of Induction through 2 minutes after successful intubation |
| Time to Intubation | Time (in minutes) from pushing of induction meds to successful placement of endotracheal tube | Time of Induction through 2 minutes after successful intubation |
| Need for Assistance | Incidence of need for additional intubating equipment, second operator | Time of Induction through 2 minutes after successful intubation |
| Non-hypoxic complications | Incidence of non-oxygenation complications - composite of all other recorded complications | Time of Induction through 2 minutes after successful intubation |
| Malposition of Endotracheal Tube | Incidence of post-intubation tube malposition on Chest X-Ray (CXR) | Time of Induction through 2 minutes after successful intubation |
| Repositioning Patient | Incidence of repositioning patient after procedure initiation | Time of Induction through 2 minutes after successful intubation |
| In-Hospital Mortality | Death before hospital discharge | From enrollment through the earlier of hospital discharge or 365 days |
| Ventilator-free Days | Days alive and free from mechanical ventilation | From enrollment through study day 28 |
| ICU-Free Days | Days alive and out of the ICU | From enrollment through study day 28 |
| New Orleans |
| Louisiana |
| 70112 |
| United States |
| Ochsner Medical Center | New Orleans | Louisiana | 70115 | United States |
| Vanderbilt University | Nashville | Tennessee | 37232 | United States |
| University of Washington | Seattle | Washington | 98104 | United States |
| Semler MW, Janz DR, Russell DW, Casey JD, Lentz RJ, Zouk AN, deBoisblanc BP, Santanilla JI, Khan YA, Joffe AM, Stigler WS, Rice TW; Check-UP Investigators( *); Pragmatic Critical Care Research Group. A Multicenter, Randomized Trial of Ramped Position vs Sniffing Position During Endotracheal Intubation of Critically Ill Adults. Chest. 2017 Oct;152(4):712-722. doi: 10.1016/j.chest.2017.03.061. Epub 2017 May 6. |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |