Pragmatic Trial Examining Oxygenation Prior to Intubation

NCT05267652 | Completed Results DMC

• 1 other identifier: 211271
• Study Type: interventional
• Target: 1,301
• Locations: 1 country
• Sites: 16

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 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

Keywords

Critical illness; Emergency airway management; Tracheal intubation; Non-invasive ventilation; Facemask oxygen

Outcome Measures

Primary Outcomes (1)

• Incidence of Hypoxemia

  A peripheral oxygen saturation \< 85% during the interval between induction and 2 minutes after tracheal intubation

  from induction to 2 minutes following tracheal intubation

Secondary Outcomes (1)

• Lowest Oxygen Saturation

  from induction to 2 minutes following tracheal intubation

Other Outcomes (19)

• Incidence of Operator-reported Aspiration

  from induction to 2 minutes following tracheal intubation

• Fraction of Inspired Oxygen at 24 Hours After Induction

  24 hours after induction

• Oxygen Saturation at 24 Hours After Induction

  24 hours after induction

Study Arms (2)

Preoxygenation with Non-Invasive Positive Pressure Ventilation Group

ACTIVE COMPARATOR

Patients assigned to preoxygenation with non-invasive positive pressure ventilation will receive 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: Preoxygenation with Non-Invasive Positive Pressure Ventilation

Preoxygenation with Facemask Oxygen Group

ACTIVE COMPARATOR

For patients randomized to preoxygenation with facemask oxygen, supplemental oxygen will be administered 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.

Other: Facemask Oxygen

Interventions

Preoxygenation with Non-Invasive Positive Pressure Ventilation OTHER

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.

Preoxygenation with Non-Invasive Positive Pressure Ventilation Group

Facemask Oxygen OTHER

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.

Preoxygenation with Facemask Oxygen Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• University of Colorado, Denver: collaborator

Study Sites (16)

UAB Hospital

Birmingham, Alabama, 35233, United States

Location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

Our Lady of the Lake Regional Medical Center

Baton Rouge, Louisiana, 70808, United States

Location

Ochsner Medical Center | Ochsner Health System

New Orleans, Louisiana, 70112, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

The Lahey Hospital & Medical Center

Burlington, Massachusetts, 01805, United States

Location

Hennepin County Medical Center

Minneapolis, Minnesota, 55415, United States

Location

Montefiore Medical Center

The Bronx, New York, 10467, United States

Location

Wake Forest Baptist Medical Center

Winston-Salem, North Carolina, 27157, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Brooke Army Medical Center

Fort Sam Houston, Texas, 78234, United States

Location

Baylor Scott & White Health

Temple, Texas, 76508, United States

Location

University of Wisconsin-Madison

Madison, Wisconsin, 53705, United States

Location

Related Publications (2)

• Gibbs KW, Semler MW, Driver BE, Seitz KP, Stempek SB, Taylor C, Resnick-Ault D, White HD, Gandotra S, Doerschug KC, Mohamed A, Prekker ME, Khan A, Gaillard JP, Andrea L, Aggarwal NR, Brainard JC, Barnett LH, Halliday SJ, Blinder V, Dagan A, Whitson MR, Schauer SG, Walker JE Jr, Barker AB, Palakshappa JA, Muhs A, Wozniak JM, Kramer PJ, Withers C, Ghamande SA, Russell DW, Schwartz A, Moskowitz A, Hansen SJ, Allada G, Goranson JK, Fein DG, Sottile PD, Kelly N, Alwood SM, Long MT, Malhotra R, Shapiro NI, Page DB, Long BJ, Thomas CB, Trent SA, Janz DR, Rice TW, Self WH, Bebarta VS, Lloyd BD, Rhoads J, Womack K, Imhoff B, Ginde AA, Casey JD; PREOXI Investigators and the Pragmatic Critical Care Research Group. Noninvasive Ventilation for Preoxygenation during Emergency Intubation. N Engl J Med. 2024 Jun 20;390(23):2165-2177. doi: 10.1056/NEJMoa2313680. Epub 2024 Jun 13.

  PMID: 38869091 DERIVED

• Gibbs KW, Ginde AA, Prekker ME, Seitz KP, Stempek SB, Taylor C, Gandotra S, White H, Resnick-Ault D, Khan A, Mohmed A, Brainard JC, Fein DG, Aggarwal NR, Whitson MR, Halliday SJ, Gaillard JP, Blinder V, Driver BE, Palakshappa JA, Lloyd BD, Wozniak JM, Exline MC, Russell DW, Ghamande S, Withers C, Hubel KA, Moskowitz A, Bastman J, Andrea L, Sottile PD, Page DB, Long MT, Goranson JK, Malhotra R, Long BJ, Schauer SG, Connor A, Anderson E, Maestas K, Rhoads JP, Womack K, Imhoff B, Janz DR, Trent SA, Self WH, Rice TW, Semler MW, Casey JD. Protocol and statistical analysis plan for the PREOXI trial of preoxygenation with noninvasive ventilation vs oxygen mask. medRxiv [Preprint]. 2023 Mar 24:2023.03.23.23287539. doi: 10.1101/2023.03.23.23287539.

  PMID: 36993496 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Jonathan D Casey, MD, MSc
• Organization: Vanderbilt University Medical Center

Jonathan.d.Casey@vumc.org

615-875-4681

Study Officials

• Jonathan D Casey, MD, MSc

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Adit A Ginde, MD, MPH

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Matthew W Semler, MD, MSc

  Vanderbilt University Medical Center

  STUDY DIRECTOR

• Kevin W Gibbs, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 4, 2022
• Study Start: March 10, 2022
• Primary Completion: October 14, 2023
• Study Completion: November 11, 2023
• Last Updated: December 9, 2024
• Results First Posted: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Following publication. No end date
• Access Criteria: 1. a signed data access agreement 2. research testing a hypothesis 3. a protocol that has been approved by an institutional review board 4. a proposal that has received approval from the principal investigator

Locations

US (16)