Oxygen Therapy Strategy for Burns
(SAVE-O2 Trial)

Recruiting in Palo Alto (17 mi)

+5 other locations

Overseen byAdit Ginde, MD, MPH

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: University of Colorado, Denver

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?The objective is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in major burn patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.

Eligibility Criteria

This trial is for adult patients with severe burn injuries who are admitted to a burn unit within a day of the injury. It's not for pregnant women, children under 18, or prisoners. Participants should be eligible for inclusion in state or national burn data repositories.

Inclusion Criteria

I was admitted to a burn unit within a day of getting burned.

Patients with acute thermal burn injury who meet the criteria for entry into the state or national burn data repository

Exclusion Criteria

Prisoners

I am under 18 years old.

Known pregnancy

Participant Groups

The study tests an educational strategy aimed at using oxygen more precisely in major burn patients (keeping blood oxygen levels within specific ranges). The goal is to see if this approach reduces unnecessary supplemental oxygen use and improves patient outcomes.

2Treatment groups

Active Control

Group I: Post-Implementation Targeting Normoxemia in Burn ICUActive Control1 Intervention

The intervention (post-implementation) group will be patients admitted to the burn unit in ICU during the targeting normoxemia intervention period of the stepped-wedge design implementation process (up to 19 months).

Group II: Pre-ImplementationActive Control1 Intervention

The control (pre-implementation) group will be burn patients admitted to the burn unit in ICU during the site's control period of the stepped-wedge implementation process (up to 22 months).