Brief Summary

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.

Trial Health

Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at below P25 for not_applicable

Timeline

Completed

Started Mar 2019

Geographic Reach

1 country

1 active site

Status

terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.1 years study duration

First Submitted

Initial submission to the registry

September 11, 2018

Completed

22 days until next milestone

First Posted

Study publicly available on registry

October 3, 2018

Completed

5 months until next milestone

Study Start

First participant enrolled

March 1, 2019

Completed

1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 22, 2020

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 22, 2020

Completed

Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

1.1 years

First QC Date

September 11, 2018

Last Update Submit

March 22, 2020

Conditions

Apneic Oxygenation Endotracheal Intubation

Keywords

Apneic OxygenationEndotracheal intubationAirway ManagementEmergency Department

Outcome Measures

Primary Outcomes (1)

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 Outcomes (14)

Lowest oxygen saturation precipitous intubations
Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation
Lowest oxygen saturation pre-oxygenation
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
Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation
+9 more secondary outcomes

Study Arms (2)