- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02961933
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 Contact
- Name: Valerie Aston, MBA, RT
- Phone Number: 801-507-4606
- Email: Valerie.Aston@imail.org
Study Locations
-
-
Utah
-
Murray, Utah, United States, 84107
- Recruiting
- Intermountain Medical Center
-
Contact:
- Valerie Aston, MBA, RT
- Phone Number: 801-507-4606
- Email: Valerie.Aston@imail.org
-
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
|
Nasal cannula apneic oxygenation
|
Active Comparator: non-apneic oxygenation
|
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
Collaborators
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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