Status:
COMPLETED
Pragmatic Trial Examining Oxygenation Prior to Intubation
Lead Sponsor:
Vanderbilt University Medical Center
Collaborating Sponsors:
University of Colorado, Denver
Conditions:
Acute Respiratory Failure
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Clinicians perform rapid sequence induction, laryngoscopy, and tracheal intubation for more than 5 million critically ill adults as a part of clinical care each year in the United States. One-in-ten e...
Detailed Description
BACKGROUND: Clinicians frequently perform tracheal intubation of critically ill patients in the emergency department (ED) or intensive care unit (ICU). Complications of intubation, including hypoxemi...
Eligibility Criteria
Inclusion
- Patient is located in a participating unit
- Planned procedure is tracheal intubation using a laryngoscope and sedation
- Planned operator is a clinician expected to routinely perform tracheal intubation in the participating unit.
Exclusion
- Patient is receiving positive pressure ventilation by a mechanical ventilator, bag-mask device, or laryngeal mask airway
- Patient is known to be less than 18 years old
- Patient is known to be pregnant
- Patient is known to be a prisoner
- Immediate need for tracheal intubation precludes safe performance of study procedures
- Patient is apneic, hypopneic, or has another condition requiring positive pressure ventilation between enrollment and induction
- Operator has determined that preoxygenation with non-invasive positive pressure ventilation or preoxygenation with a facemask is required or contraindicated for optimal care of the patient
Key Trial Info
Start Date :
March 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 11 2023
Estimated Enrollment :
1301 Patients enrolled
Trial Details
Trial ID
NCT05267652
Start Date
March 10 2022
End Date
November 11 2023
Last Update
December 9 2024
Active Locations (16)
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1
UAB Hospital
Birmingham, Alabama, United States, 35233
2
University of Colorado Denver
Aurora, Colorado, United States, 80045
3
University of Iowa
Iowa City, Iowa, United States, 52242
4
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States, 70808