Utah Study Evaluating Apneic Oxygenation for Emergency Department Intubation (USE AP OX)

February 10, 2020 updated by: Intermountain Health Care, Inc.
This study will determine rates of first pass success without hypoxemia in emergency department intubations with and without the use of apneic oxygenation by nasal cannula.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Medical Center
        • Contact:
        • Principal Investigator:
          • Rob Bryant, MD
        • Sub-Investigator:
          • Joseph Bledsoe, MD
        • Sub-Investigator:
          • Hill Stoecklein, MD
        • Sub-Investigator:
          • Megan Fix, MD
        • Sub-Investigator:
          • Amber Bledsoe, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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:

- Patients requiring emergent Rapid Sequence or Delayed Sequence endotracheal intubation with administration of a neuromuscular blocker (Succinylcholine, Rocuronium)

Exclusion Criteria:

  • Known prisoners
  • Patients in cardiac arrest
  • Patients who are intubated without the use of neuromuscular blockade (i.e., cardiac arrest, awake intubation).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Apneic oxygenation
Other: Apneic oxygenation
Nasal cannula apneic oxygenation
Active Comparator: non-apneic oxygenation
Other: Pre-oxgenation with NRB, NIPPV, BVM
Pre-oxygenation with non-rebreather mask, non-invasive positive pressure ventilation, or bag-valve mask

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
First pass success without hypoxemia
Time Frame: 10 minutes
10 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in peri-intubation saturation
Time Frame: 0, 30, 60 and 120 seconds
0, 30, 60 and 120 seconds
Saturation at time of tube placement
Time Frame: 10 minutes
10 minutes
Time to desaturation <93%
Time Frame: measured time until saturations drop below 93% during the peri-intubation period, up to 10 minutes
measured time until saturations drop below 93% during the peri-intubation period, up to 10 minutes
Saturation at post intubation
Time Frame: 0, 30, 60, and 120 seconds
0, 30, 60, and 120 seconds

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Intermountain Health Care, Inc.

Collaborators

University of Utah

Investigators

  • Principal Investigator: Robert Bryant, MD, Intermountain Health Care, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

January 1, 2020

Study Completion (Anticipated)

June 1, 2020

Study Registration Dates

First Submitted

November 1, 2016

First Submitted That Met QC Criteria

November 8, 2016

First Posted (Estimate)

November 11, 2016

Study Record Updates

Last Update Posted (Actual)

February 11, 2020

Last Update Submitted That Met QC Criteria

February 10, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1050200

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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