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Apneic Oxygenation Including Precipitous Intubations During RSI in the ED

Not Applicable
Terminated
Conditions
Endotracheal Intubation
Apneic Oxygenation
Interventions
Other: Apneic oxygenation during endotracheal intubation
Registration Number
NCT03694379
Lead Sponsor
Rutgers, The State University of New Jersey
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
10
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Apneic OxygenationApneic oxygenation during endotracheal intubationParticipants receiving apneic oxygenation
Primary Outcome Measures
NameTimeMethod
Lowest oxygen saturation overallTime between neuromuscular blockade and 2 minutes after completion of endotracheal intubation

Lowest oxygen saturation between overall control and intervention groups

Secondary Outcome Measures
NameTimeMethod
Difference in baseline and final oxygen saturationDecision to intubate through 2 minutes after completion of endotracheal intubation
DesaturationInitiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation

The proportion of patients who desaturate below 90%

Hospital length of stayUp to 28 days after intubation

Number of days patient is hospitalized

Number of days intubatedUp to 28 days after intubation
Lowest oxygen saturation precipitous intubationsTime between neuromuscular blockade and 2 minutes after completion of endotracheal intubation

Lowest oxygen saturation between control and intervention groups that did not receive adequate pre-oxygenation only

Need for second operatorFrom first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.

A second physician had to attempt intubation

In-hospital mortalityUp to 28 days after intubation
Difference in oxygen saturation before and after apneic periodInitiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation
Procedural hypotensionInitiation of neuromuscular blockade to 2 minutes after completion of endotracheal intubation

Proportion of became hypotensive at any point during the intubation procedure

Need for additional intubating equipmentFrom first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.

The operator needed to change or add equipment to facilitate intubation

AspirationWithin 24 hours after intubation procedure was complete

Proportion of patients that had evidence of aspiration

Lowest oxygen saturation pre-oxygenationTime between neuromuscular blockade and 2 minutes after completion of endotracheal intubation

Lowest oxygen saturation between control and intervention groups that did receive

number of attemptsFrom first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.

number of times laryngoscope is placed into the mouth in an attempt to pass an endotracheal tube

Esophageal intubationsFrom first attempt at intubation through entire ED stay, approximately 6 hours.

The proportion of intubations that resulted in the endotracheal tube being placed in the esophagus

Trial Locations

Locations (1)

University Hospital

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Newark, New Jersey, United States

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