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

Primary Purpose

Apneic Oxygenation, Endotracheal Intubation

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Apneic oxygenation during endotracheal intubation
Sponsored by
Rutgers, The State University of New Jersey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Apneic Oxygenation focused on measuring Apneic Oxygenation, Endotracheal intubation, Airway Management, Emergency Department

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Apneic Oxygenation

No Apneic Oxygenation

Arm Description

Participants receiving apneic oxygenation

Participants not receiving apneic oxygenation

Outcomes

Primary Outcome Measures

Lowest oxygen saturation overall
Lowest oxygen saturation between overall control and intervention groups

Secondary Outcome Measures

Lowest oxygen saturation precipitous intubations
Lowest oxygen saturation between control and intervention groups that did not receive adequate pre-oxygenation only
Lowest oxygen saturation pre-oxygenation
Lowest oxygen saturation between control and intervention groups that did receive
Difference in baseline and final oxygen saturation
Difference in oxygen saturation before and after apneic period
Desaturation
The proportion of patients who desaturate below 90%
number of attempts
number of times laryngoscope is placed into the mouth in an attempt to pass an endotracheal tube
Need for second operator
A second physician had to attempt intubation
Need for additional intubating equipment
The operator needed to change or add equipment to facilitate intubation
Esophageal intubations
The proportion of intubations that resulted in the endotracheal tube being placed in the esophagus
Procedural hypotension
Proportion of became hypotensive at any point during the intubation procedure
Aspiration
Proportion of patients that had evidence of aspiration
Hospital length of stay
Number of days patient is hospitalized
Number of days intubated
In-hospital mortality

Full Information

First Posted
September 11, 2018
Last Updated
March 22, 2020
Sponsor
Rutgers, The State University of New Jersey
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1. Study Identification

Unique Protocol Identification Number
NCT03694379
Brief Title
Apneic Oxygenation Including Precipitous Intubations During RSI in the ED
Acronym
RAPID
Official Title
Randomized Controlled Trial of Apneic Oxygenation Including Precipitous Intubations During RSI in the Emergency Department
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
Could not enroll enough patients
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
March 22, 2020 (Actual)
Study Completion Date
March 22, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rutgers, The State University of New Jersey

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Apneic Oxygenation, Endotracheal Intubation
Keywords
Apneic Oxygenation, Endotracheal intubation, Airway Management, Emergency Department

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Apneic Oxygenation
Arm Type
Experimental
Arm Description
Participants receiving apneic oxygenation
Arm Title
No Apneic Oxygenation
Arm Type
No Intervention
Arm Description
Participants not receiving apneic oxygenation
Intervention Type
Other
Intervention Name(s)
Apneic oxygenation during endotracheal intubation
Intervention Description
Providing oxygenation through nasal cannula during the apneic phase of endotracheal intubation.
Primary Outcome Measure Information:
Title
Lowest oxygen saturation overall
Description
Lowest oxygen saturation between overall control and intervention groups
Time Frame
Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation
Secondary Outcome Measure Information:
Title
Lowest oxygen saturation precipitous intubations
Description
Lowest oxygen saturation between control and intervention groups that did not receive adequate pre-oxygenation only
Time Frame
Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation
Title
Lowest oxygen saturation pre-oxygenation
Description
Lowest oxygen saturation between control and intervention groups that did receive
Time Frame
Time between neuromuscular blockade and 2 minutes after completion of endotracheal intubation
Title
Difference in baseline and final oxygen saturation
Time Frame
Decision to intubate through 2 minutes after completion of endotracheal intubation
Title
Difference in oxygen saturation before and after apneic period
Time Frame
Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation
Title
Desaturation
Description
The proportion of patients who desaturate below 90%
Time Frame
Initiation of neuromuscular blockade through 2 minutes after completion of endotracheal intubation
Title
number of attempts
Description
number of times laryngoscope is placed into the mouth in an attempt to pass an endotracheal tube
Time Frame
From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.
Title
Need for second operator
Description
A second physician had to attempt intubation
Time Frame
From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.
Title
Need for additional intubating equipment
Description
The operator needed to change or add equipment to facilitate intubation
Time Frame
From first attempt at intubation through completion of endotracheal intubation procedure, approximately 2 minutes.
Title
Esophageal intubations
Description
The proportion of intubations that resulted in the endotracheal tube being placed in the esophagus
Time Frame
From first attempt at intubation through entire ED stay, approximately 6 hours.
Title
Procedural hypotension
Description
Proportion of became hypotensive at any point during the intubation procedure
Time Frame
Initiation of neuromuscular blockade to 2 minutes after completion of endotracheal intubation
Title
Aspiration
Description
Proportion of patients that had evidence of aspiration
Time Frame
Within 24 hours after intubation procedure was complete
Title
Hospital length of stay
Description
Number of days patient is hospitalized
Time Frame
Up to 28 days after intubation
Title
Number of days intubated
Time Frame
Up to 28 days after intubation
Title
In-hospital mortality
Time Frame
Up to 28 days after intubation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ilya Ostrovsky, MD
Organizational Affiliation
Rutgers, The State University of New Jersey
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07103
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Apneic Oxygenation Including Precipitous Intubations During RSI in the ED

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