Pragmatic Trial Examining Oxygenation Prior to Intubation

Completed · Not applicable

Conditions studied: Acute Respiratory Failure

In brief

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 emergency tracheal intubations is complicated by life-threatening hypoxemia. Administering supplemental oxygen prior to induction and intubation ("preoxygenation") decreases the risk of life-threatening hypoxemia. In current clinical practice, the most common methods for preoxygenation are non-invasive positive pressure ventilation and facemask oxygen. Prior trials comparing non-invasive positive pressure ventilation and facemask oxygen for preoxygenation have been small and have yielded conflicting results. A better understanding of the comparative effectiveness of these two common, standard-of-care approaches to preoxygenation could improve the care clinicians deliver and patient outcomes.

Key facts

Study ID

NCT05267652

Run by

Vanderbilt University Medical Center

People needed

1301

Starts

2022-03-10

Expected to finish

2023-11-11

Last updated by the study team

2024-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• UAB Hospital — Birmingham, Alabama, United States
• University of Colorado Denver — Aurora, Colorado, United States
• University of Iowa — Iowa City, Iowa, United States
• Our Lady of the Lake Regional Medical Center — Baton Rouge, Louisiana, United States
• Ochsner Medical Center | Ochsner Health System — New Orleans, Louisiana, United States
• Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States
• The Lahey Hospital & Medical Center — Burlington, Massachusetts, United States
• Hennepin County Medical Center — Minneapolis, Minnesota, United States
• Montefiore Medical Center — The Bronx, New York, United States
• Wake Forest Baptist Medical Center — Winston-Salem, North Carolina, United States
• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Brooke Army Medical Center — Fort Sam Houston, Texas, United States
• Baylor Scott & White Health — Temple, Texas, United States
• University of Wisconsin-Madison — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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