Pragmatic Trial Examining Oxygenation Prior to Intubation

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 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.

Conditions

• Acute Respiratory Failure

Interventions

OTHER

Preoxygenation with Non-Invasive Positive Pressure Ventilation

The delivery of oxygen and ventilation by non-invasive mechanical ventilation via a tight-fitting mask from the initiation of preoxygenation until the initiation of laryngoscopy. Trial protocol will not dictate the brand or type of mechanical ventilator that will be used to deliver non-invasive ventilation.

OTHER

Facemask Oxygen

The delivery of supplemental oxygen via a non-rebreather mask or bag-mask device without manual ventilation from the initiation of preoxygenation until induction. Trial protocol will not dictate the brand or type of facemask. The decision between use of a non-rebreather mask and use of a bag-mask device will be made by treating clinicians. The decision of whether to provide manual ventilation with a bag-mask device between induction and laryngoscopy will be made by treating clinicians.

Sponsors & Collaborators

• University of Colorado, Denver

  collaborator OTHER

• Vanderbilt University Medical Center

  lead OTHER

Principal Investigators

• Jonathan D Casey, MD, MSc · Vanderbilt University Medical Center

• Adit A Ginde, MD, MPH · University of Colorado, Denver

• Matthew W Semler, MD, MSc · Vanderbilt University Medical Center

• Kevin W Gibbs, MD · Wake Forest University Health Sciences

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-03-10

Primary Completion

2023-10-14

Completion

2023-11-11

Countries

• United States

Study Locations