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Preoxygenation with Non-Invasive Positive Pressure Ventilation and Facemask Oxygen for Acute Respiratory Failure and Respiratory Insufficiency (PREOXI Trial)

N/A

Waitlist Available

Led By Adit A Ginde, MD, MPH

Research Sponsored by Vanderbilt University Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up duration of procedure (minutes)

Awards & highlights

PREOXI Trial Summary

This trial compares the effectiveness of two common methods for preoxygenation (non-invasive positive pressure ventilation and facemask oxygen) for preventing life-threatening hypoxemia during emergency tracheal intubation.

Eligible Conditions

Acute Respiratory Failure

PREOXI Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 28 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~28 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of Hypoxemia

Secondary outcome measures

Lowest oxygen saturation

Other outcome measures

28-day in-hospital mortality

Cormack-Lehane grade of glottic view on first attempt

Duration from induction to successful intubation

+16 more

PREOXI Trial Design

2Treatment groups

Active Control

Group I: Preoxygenation with Non-Invasive Positive Pressure Ventilation GroupActive Control1 Intervention

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.

Group II: Preoxygenation with Facemask Oxygen GroupActive Control1 Intervention

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.

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Find a Location

Who is running the clinical trial?

Vanderbilt University Medical CenterLead Sponsor

856 Previous Clinical Trials

670,891 Total Patients Enrolled

6 Trials studying Acute Respiratory Failure

8,464 Patients Enrolled for Acute Respiratory Failure

University of Colorado, DenverOTHER

1,732 Previous Clinical Trials

2,142,247 Total Patients Enrolled

2 Trials studying Acute Respiratory Failure

1,540 Patients Enrolled for Acute Respiratory Failure

Matthew W Semler, MD, MScStudy DirectorVanderbilt University Medical Center

6 Previous Clinical Trials

7,616 Total Patients Enrolled

3 Trials studying Acute Respiratory Failure

4,890 Patients Enrolled for Acute Respiratory Failure

Media Library

Facemask Oxygen Clinical Trial Eligibility Overview. Trial Name: NCT05267652 — N/A

Acute Respiratory Failure Research Study Groups: Preoxygenation with Non-Invasive Positive Pressure Ventilation Group, Preoxygenation with Facemask Oxygen Group

Acute Respiratory Failure Clinical Trial 2023: Facemask Oxygen Highlights & Side Effects. Trial Name: NCT05267652 — N/A

Facemask Oxygen 2023 Treatment Timeline for Medical Study. Trial Name: NCT05267652 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are being accepted for this clinical research?

"Affirmative. Clinical trials hosted on clinicaltrials.gov reveal that this research is actively enrolling participants, having initially been posted on March 7th 2022 and most recently updated November 30th 2022. 1300 patients must be recruited from 14 distinct medical sites for the study to commence."

Answered by AI

How many sites are engaged in carrying out this clinical investigation?

"This clinical trial is currently enrolling patients at a total of 14 distinct medical sites, such as Our Lady of the Lake Regional Medical Center in Baton Rouge, University of Wisconsin-Madison in Madison, and University of Colorado Denver in Aurora."

Answered by AI

Are there any vacancies for volunteers in this research endeavor?

"Accurately, clinicaltrials.gov reveals that this medical trial is currently recruiting applicants who meet the criteria. It was first listed on March 7th 2022 and has been updated as of November 30th 2022; 1300 patients need to be recruited across 14 sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Pragmatic Trial Examining Oxygenation Prior to Intubation

Jonathan Casey 2022. "Pragmatic Trial Examining Oxygenation Prior to Intubation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05267652.