Apneic Oxygenation Including Precipitous Intubations During RSI in the ED

Study Overview
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Brief Summary
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This RCT is testing the efficacy of apneic oxygenation during endotracheal intubation in the emergency department. Currently the standard practice in the ED when performing endotracheal intubation is that some providers use apneic oxygenation (the application of a nasal cannula at 15LPM) throughout the intubation procedure, while others do not apply apneic oxygenation. Initial literature in the operating room showed that apneic oxygenation helps prevent desaturation during the procedure. However, the latest literature conducted in critical care settings (one study in the ICU and one in the ED) questions the efficacy of this intervention in critically ill patients; however, no harm has been shown. Our study aims to test this intervention further by adding in a special subset of patients that was excluded from prior studies, precipitous intubations, or those patients that have to be intubated quickly and cannot have adequate pre-oxygenation. We hypothesize that apneic oxygenation will be more efficacious in this subset than in the overall ED population. We will randomize patients requiring endotracheal intubation into intervention (apneic oxygenation) and control (no apneic oxygenation). We will measure the lowest arterial oxygen saturation from the start of the intubation procedure through 2 minutes after intubation is complete.

Official Title
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Randomized Controlled Trial of Apneic Oxygenation Including Precipitous Intubations During RSI in the Emergency Department

Conditions
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Apneic Oxygenation, Endotracheal Intubation

Intervention / Treatment
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* Other: Apneic oxygenation during endotracheal intubation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The inclusion criteria for our study will include patients 18 years or older who require emergent endotracheal intubation utilizing rapid sequence intubation (RSI) in the Emergency Department with first attempt taken by a resident or attending physician working in the emergency department. This includes Emergency Medicine attending physicians and residents as well as non-Emergency Medicine rotators (e.g.., Internal Medicine residents who are rotating through the Emergency Department). Exclusion Criteria: Exclusion criteria include patients who are in cardiac arrest, or if the patient received any positive pressure ventilation (i.e, BPAP, CPAP, BVM) in the emergency department before RSI.

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Apneic Oxygenation<br>Participants receiving apneic oxygenation | Other: Apneic oxygenation during endotracheal intubation<br>* Providing oxygenation through nasal cannula during the apneic phase of endotracheal intubation.<br>|
| No Intervention: No Apneic Oxygenation<br>Participants not receiving apneic oxygenation | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowest oxygen saturation overall | Lowest oxygen saturation between overall control and intervention groups | Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lowest oxygen saturation precipitous intubations | Lowest oxygen saturation between control and intervention groups that did not receive adequate pre-oxygenation only | Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation | 
| Lowest oxygen saturation pre-oxygenation | Lowest oxygen saturation between control and intervention groups that did receive | Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation | 
| Difference in baseline and final oxygen saturation |  | Decision to intubate through 2 minutes after completion of endotracheal intubation | 
| Difference in oxygen saturation before and after apneic period |  | Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation | 
| Desaturation | The proportion of patients who desaturate below 90% | Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation | 
| number of attempts | number of times laryngoscope is placed into the mouth in an attempt to pass an endotracheal tube | From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes. | 
| Need for second operator | A second physician had to attempt intubation | From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes. | 
| Need for additional intubating equipment | The operator needed to change or add equipment to facilitate intubation | From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes. | 
| Esophageal intubations | The proportion of intubations that resulted in the endotracheal tube being placed in the esophagus | From first attempt at intubation through entire ED stay, approximately 6 hours. | 
| Procedural hypotension | Proportion of became hypotensive at any point during the intubation procedure | Initiation of neuromuscular blockade to 2 minutes after completion of endotracheal intubation | 
| Aspiration | Proportion of patients that had evidence of aspiration | Within 24 hours after intubation procedure was complete | 
| Hospital length of stay | Number of days patient is hospitalized | Up to 28 days after intubation | 
| Number of days intubated |  | Up to 28 days after intubation | 
| In-hospital mortality |  | Up to 28 days after intubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Apneic Oxygenation, Endotracheal intubation, Airway Management, Emergency Department