Apneic Oxygenation Including Precipitous Intubations During RSI in the ED

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Ilya Ostrovsky, MD，Rutgers, The State University of New Jersey

Tracking Information

First Submitted Date ^ICMJE

September 11, 2018

First Posted Date ^ICMJE

October 3, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

October 2018

Estimated Primary Completion Date

October 31, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Lowest oxygen saturation overall[ Time Frame: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation ]

Lowest oxygen saturation between overall control and intervention groups

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Lowest oxygen saturation precipitous intubations[ Time Frame: Time 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
Lowest oxygen saturation pre-oxygenation[ Time Frame: Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation ]
Lowest oxygen saturation between control and intervention groups that did receive
Difference in baseline and final oxygen saturation[ Time Frame: Decision to intubate through 2 minutes after completion of endotracheal intubation ]
Difference in oxygen saturation before and after apneic period[ Time Frame: Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation ]
Desaturation[ Time Frame: Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation ]
The proportion of patients who desaturate below 90%
number of attempts[ Time Frame: From 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
Need for second operator[ Time Frame: From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes. ]
A second physician had to attempt intubation
Need for additional intubating equipment[ Time Frame: From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes. ]
The operator needed to change or add equipment to facilitate intubation
Esophageal intubations[ Time Frame: From 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
Procedural hypotension[ Time Frame: Initiation of neuromuscular blockade to 2 minutes after completion of endotracheal intubation ]
Proportion of became hypotensive at any point during the intubation procedure
Aspiration[ Time Frame: Within 24 hours after intubation procedure was complete ]
Proportion of patients that had evidence of aspiration
Hospital length of stay[ Time Frame: Up to 28 days after intubation ]
Number of days patient is hospitalized
Number of days intubated[ Time Frame: Up to 28 days after intubation ]
In-hospital mortality[ Time Frame: Up to 28 days after intubation ]

Descriptive Information

Brief Title ^ICMJE

Apneic Oxygenation Including Precipitous Intubations During RSI in the ED

Official Title ^ICMJE

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

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

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Prevention

Condition ^ICMJE

Intervention ^ICMJE

Other: Apneic oxygenation during endotracheal intubation
Providing oxygenation through nasal cannula during the apneic phase of endotracheal intubation.

Study Arms

Experimental: Apneic Oxygenation
Participants receiving apneic oxygenation
No Intervention: No Apneic Oxygenation
Participants not receiving apneic oxygenation

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

346

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

October 2019

Estimated Primary Completion Date

October 31, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Ilya Ostrovsky, MD，Rutgers, The State University of New Jersey

Study Sponsor ^ICMJE

Rutgers, The State University of New Jersey

Collaborators ^ICMJE

Investigators ^ICMJE

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

PRS Account

Rutgers, The State University of New Jersey

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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