Oxygen Therapy Strategy for Burns

(SAVE-O2 Trial)

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

2000 Participants Needed

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.

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.

What data supports the effectiveness of the treatment targeting normoxemia and normoxia for burn patients?

Research suggests that maintaining targeted normoxia (a balanced level of oxygen in the blood) may improve outcomes in critically ill patients by avoiding harmful levels of oxygen. This approach is being studied in trauma patients, which may provide insights applicable to burn patients. ^{1 2 3 4 5}

Is oxygen therapy safe for treating burns?

Oxygen therapy can be risky for burn patients, especially if they are smokers, as it can lead to serious complications like inhalation injuries and even death. In a study, 83% of oxygen therapy burns were caused by smoking, and 9.6% of patients died in the hospital. ^{6 7 8 9 10}

How does the treatment targeting normoxemia differ from other treatments for burns?

This treatment focuses on maintaining normal oxygen levels in the blood (normoxemia) to manage burns, which is different from other treatments that may not specifically target oxygen levels. It aims to optimize oxygen delivery without causing oxygen toxicity, which is a novel approach compared to standard burn care that may not prioritize oxygen balance. ^{1 3 11 12 13}

Research Team

Adit Ginde, MD, MPH

Principal Investigator

University of Colorado, Denver

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

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. United States pubmed.ncbi.nlm.nih.gov

Hyperoxic ventilation increases the tolerance of acute normovolemic anemia in anesthetized pigs. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Respiratory oxygen uptake is associated with survival in a cohort of ventilated trauma and burn patients. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Algorithm for management of pulmonary complications in burn patients. [2019]

4. England pubmed.ncbi.nlm.nih.gov

A multicenter cluster randomized, stepped wedge implementation trial for targeted normoxia in critically ill trauma patients: study protocol and statistical analysis plan for the Strategy to Avoid Excessive Oxygen (SAVE-O2) trial. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of short-term hyperoxia on sytemic hemodynamics, oxygen transport, and microcirculation: An observational study in patients with septic shock and healthy volunteers. [2020]

6. France pubmed.ncbi.nlm.nih.gov

Early respiratory manifestations of severe burn patient. [2020]

7. England pubmed.ncbi.nlm.nih.gov

Outcomes of Patients with Burns Associated with Home Oxygen Therapy: An Institutional Retrospective Review. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of blood purification in the treatment of deep burns: A systematic review and meta-analysis. [2023]

9. United States pubmed.ncbi.nlm.nih.gov

Current treatment of severely burned patients. [2019]

10. United States pubmed.ncbi.nlm.nih.gov

Combined burn and smoke inhalation injury impairs ovine hypoxic pulmonary vasoconstriction. [2020]

11. United States pubmed.ncbi.nlm.nih.gov

Oxygen therapy, oxygen therapy in medical patients hospitalized outside of the intensive care unit. [2019]

12. Russia (Federation) pubmed.ncbi.nlm.nih.gov

[Gas exchange disorders and their correction during the acute period of burn disease]. [2007]

13. United States pubmed.ncbi.nlm.nih.gov

Oxygen therapy for acute ocular chemical or thermal burns: a pilot study. [2013]