Strategy to Avoid Excessive Oxygen in Major Burn Patients (SAVE-O2)

April 2, 2024 updated by: University of Colorado, Denver

Strategy to Avoid Excessive Oxygen in Major Burn Patients (SAVE-O2)

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Oxygen therapy has undisputed importance in the care of critically ill patients to prevent secondary complications related to hypoxemia. Although routine, the practice of excessive over-oxygenation may be harmful. 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) range of 60-100 mmHg (when applicable), and a fraction of inspired oxygen (FiO2) of 21% for mechanically ventilated patients or room air for nonmechanically ventilated 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 burn patients. Investigators will also evaluate the safety and clinical effectiveness of the more targeted use of oxygen therapy.

Hypotheses: Clinical efforts to through a multimodal educational intervention will:

  1. Improve the proportion of time spent within target normoxemia thresholds (oxygen saturation [SpO2] 90-96% and/or arterial oxygen [PaO2] 60-100 mmHg [when applicable])
  2. Limiting use of excessive supplemental oxygen
  3. Reduce exposure to hyperoxemia without a substantive increase in hypoxemic episodes or adverse effects

Study Type

Interventional

Enrollment (Estimated)

2000

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama-Birmingham Medical Center
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • University of Cincinnati Medical Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • University of Pittsburgh Medical Center
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • San Antonio, Texas, United States, 78234
        • Army Institute of Surgical Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with acute thermal burn injury who meet the criteria for entry into the state or national burn data repository
  • Admission to burn unit within 24 hours of burn injury

Exclusion Criteria:

  • Age <18 years
  • Prisoners
  • Known pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Pre-Implementation
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).
Active Comparator: Post-Implementation Targeting Normoxemia in Burn ICU
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).
Other: Targeting Normoxemia (SpO2 90-96%; PaO2 60-100 mmHg)
Post-implementation of targeted normoxemia through oxygen titration for individual patients. Intervention for treatment of hypoxemia will follow usual local practice. Interventions for treatment of hyperoxemia (SpO2 >96% or PaO2 > 100 mmHg) will involve down titration of FiO2 (or supplemental oxygen for non-mechanically ventilated patients) within a time frame based on local site preferences-typically in increments of no greater than 0.10 until goal oxygenation in the normoxemia range is achieved (including room air [no supplemental oxygen] for non-mechanically ventilated patients).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Supplemental Oxygen Free Days (SOFD)
Time Frame: up to 28 days
Number of days alive and not on supplemental oxygen during the index hospitalization (0 days [worst outcome] to 28 days [best outcome])
up to 28 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital-Free Days to day 90 (HFD90)
Time Frame: up to 90 days
Number of days alive and outside the hospital (0 days [worst outcome] to 90 days [best outcome])
up to 90 days
In-hospital Mortality to day 90
Time Frame: up to 90 days
Dichotomous vital status (survived or died) at hospital discharge or day 90, whichever is first
up to 90 days
Time to Mortality to day 90
Time Frame: up to 90 days
Vital status and date of death censored at hospital discharge or day 90, whichever is first
up to 90 days
Discharge Disposition
Time Frame: up to 90 days
Defined as home (return to prior level of care) or facility (e.g., acute rehab, skilled nursing facility)
up to 90 days
Ventilator Free Days (VFD) to day 28
Time Frame: up to 28 days
Ventilator Free days = Days off ventilator (0 VFD [worst outcome] to 28 VFD [best outcome])
up to 28 days
Time to Room air
Time Frame: up to 90 days
Duration of supplemental oxygen (FiO2 = 0.21 or room air)
up to 90 days
Time to Burn Wound Healing
Time Frame: up to 90 days
Wound closure of >90% of the original burn or time to grafting (for non-full thickness wounds)
up to 90 days
Amount of Supplemental Oxygen Administered
Time Frame: up to 90 days
Total estimated oxygen volume while in the burn until after hospital arrival
up to 90 days
Duration of Time on Normoxemia Protocol Target
Time Frame: up to 90 days
Defined as SpO2 90-96% or receiving no supplemental oxygen (FiO2 0.21 or room air) while in the burn unit
up to 90 days
Proportion of Participants Receiving High Levels of Supplemental Oxygen
Time Frame: up to 90 days
FiO2>0.40 or >4 liters per minute for >2 hours while in the burn unit [excludes time in the operating room]
up to 90 days
Duration of Time Receiving High Levels of Supplemental Oxygen
Time Frame: up to 90 days
FiO2>0.40 or >4 liters per minute while in the burn unit
up to 90 days
Duration of Time Receiving No Supplemental Oxygen
Time Frame: up to 90 days
FiO2 0.21 or room air while in the burn unit
up to 90 days
Incidence of Hypoxemic Event (SpO2<88%)
Time Frame: up to 90 days
SpO2 saturation below 88% while in the burn unit
up to 90 days
Duration of Hypoxemic Events (SpO2<88%)
Time Frame: up to 90 days
SpO2 saturation below 88% while in the burn unit
up to 90 days
Incidence of Hyperoxemic Event (SpO2>96%)
Time Frame: up to 90 days
SpO2 saturation above 96% while in the burn unit
up to 90 days
Duration of Hyperoxemic Event (SpO2>96%)
Time Frame: up to 90 days
SpO2 saturation above 96% while in the burn unit
up to 90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

United States Department of Defense

Investigators

  • Principal Investigator: Adit Ginde, MD, MPH, University of Colorado, Denver

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2021

Primary Completion (Actual)

November 15, 2022

Study Completion (Estimated)

February 15, 2025

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 27, 2020

First Posted (Actual)

September 1, 2020

Study Record Updates

Last Update Posted (Actual)

April 3, 2024

Last Update Submitted That Met QC Criteria

April 2, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 19-2799

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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