Apneic Oxygenation Including Precipitous Intubations During RSI in the ED (RAPID)

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

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.

Study Overview

• Status: Terminated
• Conditions: Endotracheal Intubation; Apneic Oxygenation
• Intervention / Treatment: Other: Apneic oxygenation during endotracheal intubation

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Rutgers, The State University of New Jersey
• Investigators: Principal Investigator: Ilya Ostrovsky, MD, Rutgers, The State University of New Jersey

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2019
• Primary Completion (Actual): March 22, 2020
• Study Completion (Actual): March 22, 2020

Study Registration Dates

• First Submitted: September 11, 2018
• First Submitted That Met QC Criteria: October 1, 2018
• First Posted (Actual): October 3, 2018

Study Record Updates

• Last Update Posted (Actual): March 25, 2020
• Last Update Submitted That Met QC Criteria: March 22, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Emergency Department; Airway Management; Endotracheal intubation; Apneic Oxygenation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Apnea
• Other Study ID Numbers: Pro2018000579

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No