Facilitating EndotracheaL Intubation by Laryngoscopy Technique and Apneic Oxygenation Within the Intensive Care Unit: The FELLOW Study

Study Overview
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Brief Summary
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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.

Official Title
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Facilitating EndotracheaL Intubation by Laryngoscopy Technique and Apneic Oxygenation Within the Intensive Care Unit

Conditions
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Respiratory Failure

Intervention / Treatment
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* Device: Video Laryngoscopy
* Device: Apneic Oxygenation
* Device: Direct Laryngoscopy
* Device: No Apneic Oxygenation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults Medical ICU Patients Require endotracheal intubation Endotracheal intubation to be performed by Pulmonary/Critical Care Medicine Fellow Sedation and/or neuromuscular blockade is planned for the procedure Exclusion Criteria: Operators other than Pulmonary/Critical Care Medicine Fellows The operator predetermines that the patient requires specific intubating equipment or oxygenation technique will be required for the safe performance of the procedure

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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: VL and AO<br>Video laryngoscopy and apneic oxygenation | Device: Apneic Oxygenation<br> <br> Device: No Apneic Oxygenation<br> <br> |
| Active Comparator: DL and AO<br>Direct Laryngoscopy and apneic oxygenation | Device: Apneic Oxygenation<br> <br> Device: No Apneic Oxygenation<br> <br> |
| Active Comparator: VL and no AO<br>Video Laryngoscopy and no apneic oxygenation | Device: Video Laryngoscopy<br> <br> Device: Direct Laryngoscopy<br> <br> |
| Active Comparator: DL and no AO<br>Direct Laryngoscopy and no apneic oxygenation | Device: Video Laryngoscopy<br> <br> Device: Direct Laryngoscopy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endotracheal Intubation, Apneic Oxygenation, Respiratory failure