Clinical trial NCT03694379: Apneic Oxygenation Including Precipitous Intubations During RSI in the ED
Official title: Randomized Controlled Trial of Apneic Oxygenation Including Precipitous Intubations During RSI in the Emergency Department
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Apneic Oxygenation
Endotracheal Intubation
Keywords: Apneic Oxygenation
Endotracheal intubation
Airway Management
Emergency Department
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2018-10-03
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Lowest oxygen saturation overall
timeFrame: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation
Secondary outcomes:
measure: Lowest oxygen saturation precipitous intubations
timeFrame: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation
measure: Lowest oxygen saturation pre-oxygenation
timeFrame: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation
measure: Difference in baseline and final oxygen saturation
timeFrame: Decision to intubate through 2 minutes after completion of endotracheal intubation
measure: Difference in oxygen saturation before and after apneic period
timeFrame: Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation
measure: Desaturation
timeFrame: Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation
measure: number of attempts
timeFrame: From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.
measure: Need for second operator
timeFrame: From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.
measure: Need for additional intubating equipment
timeFrame: From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.
measure: Esophageal intubations
timeFrame: From first attempt at intubation through entire ED stay, approximately 6 hours.
measure: Procedural hypotension
timeFrame: Initiation of neuromuscular blockade to 2 minutes after completion of endotracheal intubation
measure: Aspiration
timeFrame: Within 24 hours after intubation procedure was complete
measure: Hospital length of stay
timeFrame: Up to 28 days after intubation
measure: Number of days intubated
timeFrame: Up to 28 days after intubation
measure: In-hospital mortality
timeFrame: Up to 28 days after intubation
Other outcomes:
Locations:
city: Newark
country: United States
facility: University Hospital
state: New Jersey
Study officials:
affiliation: Rutgers, The State University of New Jersey
name: Ilya Ostrovsky, MD
role: PRINCIPAL_INVESTIGATOR
References: