Oxygen Therapy Strategy for Burns

(SAVE-O2 Trial)

Not currently recruiting at 5 trial locations

Overseen By Erin Anderson, RN

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: University of Colorado, Denver

Disqualifiers: Age <18, Prisoners, Pregnancy

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to use oxygen therapy for patients with major burns. Researchers seek to determine if a special educational program can reduce unnecessary oxygen use while ensuring patient safety. The trial compares two approaches: a new oxygen therapy strategy (Targeting Normoxemia or Targeting Normoxia) and the usual care provided before the new strategy's introduction. It is suitable for those who have suffered a major thermal burn and have been admitted to a burn unit within 24 hours of injury. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants a chance to contribute to a treatment nearing widespread availability.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that maintaining balanced oxygen levels in the blood is safe for burn patients. One study found that although this method did not increase the number of days patients could go without supplemental oxygen, it ensured safe health outcomes. Experts agree that keeping oxygen levels between 90-96% is safe for patients with major burns. This suggests that maintaining balanced oxygen levels is generally well-tolerated. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different oxygen therapy strategies for burn patients, specifically targeting normoxemia and normoxia. Unlike the typical approach that might involve more generalized oxygen supplementation, these strategies aim to optimize oxygen levels more precisely. This could potentially improve recovery outcomes by ensuring that burn patients receive the most appropriate oxygen levels for healing, reducing complications associated with both excessive and insufficient oxygenation.

What evidence suggests that this trial's treatments could be effective for burn patients?

Research has shown that maintaining a balanced level of oxygen in the blood, known as normoxemia, is safe for burn patients. In this trial, one group of participants will be part of the post-implementation phase targeting normoxemia. Studies have found that this approach maintains patient health without increasing the number of days they need extra oxygen. Experts strongly support this method, recommending an oxygen saturation level between 90-96%. This strategy helps avoid excessive oxygen, which can sometimes be harmful. Although aiming for normoxemia did not increase the number of days patients were free from needing extra oxygen, it safely managed their health, suggesting it could be a promising way to treat major burns. ^{1 3 4 5 6}

Who Is on the Research Team?

Adit Ginde, MD, MPH

Principal Investigator

University of Colorado, Denver

Are You a Good Fit for This Trial?

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-Implementation

Control group of burn patients admitted to the burn unit in ICU during the site's control period

up to 22 months

Post-Implementation

Intervention group of burn patients admitted to the burn unit in ICU during the targeting normoxemia intervention period

up to 19 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

up to 90 days

What Are the Treatments Tested in This Trial?

Interventions

• Targeting Normoxemia
• Targeting Normoxia

Trial Overview 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.

How Is the Trial Designed?

Group I: Post-Implementation Targeting Normoxemia in Burn ICU Active Control 1 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-Implementation Active Control 1 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).

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40604863/

Effect of targeting normoxemia on supplemental oxygen-free ... Targeting normoxemia did not increase supplemental oxygen-free days among adults with acute thermal burns, but safely maintained clinical outcomes.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04534972

Strategy to Avoid Excessive Oxygen in Major Burn Patients An expert panel was convened and developed the strong consensus to target normoxemia at an oxygen saturation (SpO2) range of 90-96%, an arterial oxygen (PaO2) ...

3. clinicaltrial.be clinicaltrial.be/en/details/52950?per_page=20&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&not_yet_recruiting=0&completed=0&only_eligible=0&only_active=0

Strategy to Avoid Excessive Oxygen in Major Burn Patients... Specific Aim: The purpose of this study is to determine the effectiveness of a multimodal educational intervention to reduce supplemental oxygen use in major ...

4. researchgate.net researchgate.net/publication/393365513_Effect_of_targeting_normoxemia_on_supplemental_oxygen-free_days_for_adults_with_acute_thermal_burns_A_stepped_wedge_cluster_randomized_clinical_trial

Effect of targeting normoxemia on supplemental oxygen ... Surgery was required in 50 %, mechanical ventilation in 25 %. The mortality rate was 16.7 %. Infections were present in 41.7 %. Most injuries ...

5. withpower.com withpower.com/trial/phase-3-wounds-and-injuries-3-2021-2f80c

Oxygen Therapy Strategy for Burns (SAVE-O2 Trial) Research suggests that maintaining targeted normoxia (a balanced level of oxygen in the blood) may improve outcomes in critically ill patients by avoiding ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04534972

Strategy to Avoid Excessive Oxygen in Major Burn Patients An expert panel was convened and developed the strong consensus to target normoxemia at an oxygen saturation (SpO2) range of 90-96%, an arterial oxygen (PaO2) ...