Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Checklists and Upright Positioning in Endotracheal Intubation of Critically Ill Patients (Check-UP) Trial

Conditions
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Respiratory Failure

Intervention / Treatment
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* Procedure: Written Checklist
* Procedure: Head of Bed Up


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Airway management events will be included in which: Patient is admitted to the Medical Intensive Care Unit (MICU) Planned procedure is endotracheal intubation Planned operator is a Pulmonary and Critical Care Medicine (PCCM) fellow Administration of sedation and/or neuromuscular blockade is planned Age ≥ 18 years old Exclusion Criteria: Airway management events will be excluded in which: Operator feels specific patient positioning during intubation is required Urgency of intubation precludes safe performance of study procedures Operator feels an alternative pre-procedure checklist or no checklist is required

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Sniffing Position, No Checklist<br>Patient in the sniffing position without the use of a written checklist | |
| Active Comparator: Sniffing Position, Checklist<br>Patient in the sniffing position with the use of a written checklist | Procedure: Written Checklist<br>* Use of a written checklist pre and peri-intubation<br>* Other names: Checklist;|
| Active Comparator: Head of Bed Up, No Checklist<br>Patient with the head of bed up and without the use of a checklist | Procedure: Head of Bed Up<br>* Raising the patient's head of bed to 25 degrees<br>* Other names: Sniff Position;|
| Active Comparator: Head of Bed Up, Checklist<br>Patient with the head of bed up and with the use of a checklist | Procedure: Written Checklist<br>* Use of a written checklist pre and peri-intubation<br>* Other names: Checklist;Procedure: Head of Bed Up<br>* Raising the patient's head of bed to 25 degrees<br>* Other names: Sniff Position;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endotracheal Intubation, Checklist, Positioning