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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 90 days

Awards & highlights

SAVE-O2 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.Check my eligibility

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.See study design

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.

SAVE-O2 Trial 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.

SAVE-O2 Trial 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

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

Primary outcome measures

Supplemental Oxygen Free Days (SOFD)

Secondary outcome measures

Amount of Supplemental Oxygen Administered

Discharge Disposition

Duration of Hyperoxemic Event (SpO2>96%)

+13 more

SAVE-O2 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 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,732 Previous Clinical Trials

2,141,548 Total Patients Enrolled

30 Trials studying Wounds and Injuries

13,469 Patients Enrolled for Wounds and Injuries

United States Department of DefenseFED

861 Previous Clinical Trials

225,194 Total Patients Enrolled

92 Trials studying Wounds and Injuries

33,634 Patients Enrolled for Wounds and Injuries

Adit Ginde, MD, MPHPrincipal InvestigatorUniversity of Colorado, Denver

2 Previous Clinical Trials

6,572 Total Patients Enrolled

2 Trials studying Wounds and Injuries

6,572 Patients Enrolled for Wounds and Injuries

Media Library

Targeting Normoxemia (Other) Clinical Trial Eligibility Overview. Trial Name: NCT04534972 — Phase 3

Wounds and Injuries Research Study Groups: Post-Implementation Targeting Normoxemia in Burn ICU, Pre-Implementation

Wounds and Injuries Clinical Trial 2023: Targeting Normoxemia Highlights & Side Effects. Trial Name: NCT04534972 — Phase 3

Targeting Normoxemia (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04534972 — Phase 3

Frequently Asked Questions

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

Do patients over the age of 40 qualify for this trial?

"Eligible patients for this particular trial must be between 18 to 120 years old. In contrast, there are 146 clinical trials that only enroll minors and 775 that only study elderly patients."

Answered by AI

What are the requirements for participants in this trial?

"This large-scale clinical trial has looser inclusion criteria than most, only requiring that patients have disease attributes and be between 18-120 years old. They are looking to admit approximately 2000 individuals."

Answered by AI

Are there a lot of these research programs underway in our state's hospitals?

"This clinical study is being conducted at 8 different medical facilities, which are University of Cincinnati Medical Center in Cincinnati, Ohio, University of Alabama-Birmingham Medical Center in Birmingham, Alabama, Army Institute of Surgical Research in San Antonio, Texas, and 6 additional locations."

Answered by AI

What is the upper limit for the number of people who can join this clinical trial?

"That is correct, the online clinicaltrials.gov registry has information indicating that this study is looking for participants. The trial was first advertised on April 15th, 2021 and was last updated on August 2nd, 2022. There are plans to enroll 2000 individuals at 6 research facilities."

Answered by AI

Has the FDA given their blessing to Post-Implementation Targeting Normoxia in Burn ICU?

"This medical intervention has received a score of 3 for safety, as it is a Phase 3 trial. This means that there is some data supporting the efficacy of the intervention, as well as multiple rounds of data supporting its safety."

Answered by AI

Are researchers enrolling people in this trial right now?

"That is correct. The online clinicaltrials.gov registry currently lists this study as actively recruiting. The trial was first posted on 4/15/2021 and was last edited on 8/2/2022. This study is enrolling 2000 participants at 6 locations."

Answered by AI

Recent research and studies

JamaJournal

Effect of High Perioperative Oxygen Fraction on Surgical Site Infection and Pulmonary Complications After Abdominal Surgery

Meyhoff, Christian S., Jørn Wetterslev, Lars N. Jorgensen, Steen W. Henneberg, Claus Høgdall, Lene Lundvall, Poul-Erik Svendsen, et al.. 2009. “Effect of High Perioperative Oxygen Fraction on Surgical Site Infection and Pulmonary Complications After Abdominal Surgery”. Jama. American Medical Association (AMA). doi:10.1001/jama.2009.1452.

Critical Care MedicineJournal

Conservative Oxygen Therapy in Mechanically Ventilated Patients

Suzuki, Satoshi, Glenn M. Eastwood, Neil J. Glassford, Leah Peck, Helen Young, Mercedes Garcia-Alvarez, Antoine G. Schneider, and Rinaldo Bellomo. 2014. “Conservative Oxygen Therapy in Mechanically Ventilated Patients”. Critical Care Medicine. Ovid Technologies (Wolters Kluwer Health). doi:10.1097/ccm.0000000000000219.

Contemporary Clinical TrialsJournal

Design and Analysis of Stepped Wedge Cluster Randomized Trials

Hussey, Michael A., and James P. Hughes. 2007. “Design and Analysis of Stepped Wedge Cluster Randomized Trials”. Contemporary Clinical Trials. Elsevier BV. doi:10.1016/j.cct.2006.05.007.

Anaesthesia and Intensive CareJournal