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Oxygen Therapy Strategy for Burns (SAVE-O2 Trial)

Phase 3

Waitlist Available

Led By Adit Ginde, MD, MPH

Research Sponsored by University of Colorado, Denver

Eligibility Criteria Checklist

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

Must have

Admission to burn unit within 24 hours of burn injury

Be older than 18 years old

Must not have

Age <18 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 90 days

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing whether a multimodal educational intervention can help reduce the use of supplemental oxygen in major burn patients, as well as whether targeted oxygen therapy is safe and effective.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While the trial focuses on education and targeted oxygen therapy rather than drugs, potential side effects may include complications from receiving too little oxygen, like increased heart rate, shortness of breath, confusion or restlessness.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am under 18 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 90 days

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 90 days

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Supplemental Oxygen Free Days (SOFD)

Secondary study objectives

Amount of Supplemental Oxygen Administered

Discharge Disposition

Duration of Hyperoxemic Event (SpO2>96%)

+13 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

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).

0 / 2Eligibility criteria met