Evidence map›Paper›PMID 40604863›Full record

Trial reportThe journal of trauma and acute care surgery2025

Effect of targeting normoxemia on supplemental oxygen-free days for adults with acute thermal burns: A stepped wedge cluster randomized clinical trial.

David J Douin, John D Rice, Mengli Xiao, Conner L Jackson, Erin L Anderson, Alex C Cheng, Jessica Cwik, Laurel E Beaty, Jessica L Wild, Robel T Beyene and 15 more

Registry-linked trialAbstract readRandomized Controlled TrialMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The journal of trauma and acute care surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04534972 (Strategy to Avoid Excessive Oxygen in Major Burn Patients), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04534972 phase3active not recruitingnot on this map

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

TypeinterventionalSponsorUniversity of Colorado, DenverRan2021 to 2025Enrolled2,000ConditionsCritical Illness, Wounds and Injury, Disease Attributes, Pathologic ProcessesArmsTargeting Normoxemia (SpO2 90-96%, PaO2 60-100 mmHg)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Refining normoxemia targets in acute burn care: Reply.The journal of trauma and acute care surgery · 2026
    Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

25 authors.

David J DouinFrom the Department of Anesthesiology (D.J.D.), University of Colorado School of Medicine, Aurora, Colorado; Department of Biostatistics (J.D.R.), University of Michigan School of Public Health, Ann Arbor, Michigan; Department of Biostatistics and Informatics (M.X., C.L.J., L.E.B.), Colorado School of Public Health; Department of Emergency Medicine (E.L.A., J.C., A.S., V.S.B., A.A.G.), University of Colorado School of Medicine, Aurora, Colorado; Department of Biomedical Informatics (A.C.C.), Vanderbilt University Medical Center, Nashville, Tennessee; Department of Biostatistics and Informatics (J.L.W.), Colorado School of Public Health, University of Colorado Anschutz Medical Campus, Aurora, Colorado; Department of Surgery (R.T.B.), Vanderbilt University Medical Center, Nashville, Tennessee; US Army Burn Center, US Army Institute of Surgical Research (G.W.B.), Houston, Texas; Department of Medicine (G.W.B.), Meadville Medical Center, Meadville; Department of Surgery (A.C.C., J.Z.), University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania; Department of Surgery (E.L.D., J.C.S.), University of Cincinnati, Cincinnati, Ohio; Department of Surgery (J.H., J.O.J.), University of Alabama at Birmingham, Birmingham, Alabama; Vanderbilt Institute for Clinical & Translational Research (W.H.S.), Vanderbilt University Medical Center, Nashville, Tennessee; Department of Surgery (A.J.W.), University of Colorado School of Medicine, Aurora, Colorado; US Army Institute of Surgical Research (S.G.S.), Department of Emergency Medicine (S.G.S.), Brooke Army Medical Center, Joint Base San Antonio-Fort Sam Houston, San Antonio, Texas; Center for COMBAT Research (V.S.B.), University of Colorado School of Medicine, Aurora, Colorado; US Army Burn Center (L.C.), US Army Institute of Surgical Research, Fort Sam Houston, Texas.ORCID 0000-0002-5215-6854
John D Rice
Mengli Xiao
Conner L Jackson
Erin L Anderson
Alex C Cheng
Jessica Cwik
Laurel E Beaty
Jessica L Wild
Robel T Beyene
Garrett W Britton
Alain C Corcos
Elizabeth L Dale
James Hwang
Jan O Jansen
Wesley H Self
Julia C Slater
Aimee Steinwand
Arek J Wiktor
Jenny Ziembicki
Steven G Schauer
Vikhyat S Bebarta
Leopoldo Cancio
Adit A Ginde
Strategy to Avoid Excessive Oxygen (SAVE-O2) Investigators

Funding

Restoring Endothelial Function After Traumatic Injury to Reduce ARDS and Multi-Organ DysfunctionK23HL165107 · NHLBI · UNIVERSITY OF COLORADO DENVER · PI David J. Douin · 2023 to 2026
$759k
Directly measured skin pigmentation to mitigate pulse oximetry biasR03HL178873 · NHLBI · UNIVERSITY OF COLORADO DENVER · PI DOUIN, DAVID J. · 2025 to 2025
$234k
NHLBI NIH HHS K23 HL165107NHLBI NIH HHS R03 HL178873
6 · The paper itself

Abstract

backgroundSupplemental oxygen is essential in caring for adults with acute thermal burns but can expose patients to excess inspired oxygen. We sought to determine the safety and effectiveness of targeting normoxemia (peripheral oxygen saturation [SpO 2 ] 90-96%) in adults with acute thermal burns admitted to a specialized burn unit. We hypothesized that targeting normoxemia would increase the number of supplemental oxygen-free days (SOFDs) and safely reduce exposure to hyperoxemia.

methodsIn this multicenter cluster-randomized, stepped-wedge trial, we randomized six US burn centers to cross over from usual care to targeted normoxemia at three-month intervals between January 15, 2021, and October 15, 2022. In usual care, supplemental oxygen was determined by treating clinicians. In targeted normoxemia, we specified decreasing administered supplemental oxygen whenever SpO 2 was >96%. The primary outcome was SOFD, defined as the number of days alive and not receiving supplemental oxygen through Day 28. Safety outcomes included hypoxemia (SpO 2 < 88%), in-hospital mortality, and adverse events.

resultsThe 1,437 enrolled patients were mean age 48 years, 26% female, 38% with full-thickness burns, and 11% mean total body surface area burned. The proportion of time spent in normoxemia increased from 77% in the usual care group to 81% in the targeted normoxemia group. Time spent with hyperoxemia (SpO 2 > 96%) decreased from 22% to 17%, and hypoxemia was similar between groups (0.7% vs. 0.8%). The raw mean number of SOFD was 18.8 days for targeted normoxemia and 17.2 days for usual care (adjusted mean difference [aMD], 0.90 days; 95% confidence interval [CI], -0.77 to 2.57; p = 0.29). Hospital-free days through Day 90 were greater among the targeted normoxemia group (71 days) than the usual care group (70 days) (aMD, 3.47 days; 95% CI, 0.19-6.76). In-hospital mortality to Day 90 occurred in 36 (5.7%) targeted normoxemia patients and 65 (8.1%) usual care patients (adjusted hazard ratio [aHR], 0.66; 95% CI, 0.31-1.42).

conclusionTargeting normoxemia did not increase supplemental oxygen-free days among adults with acute thermal burns, but safely maintained clinical outcomes. LEVEL OF EVIDENCE: Therapeutic Care/Management; Level I.

trial registrationClinicalTrials.gov Identifier: NCT04534972.

Indexed as

BurnsOxygenOxygen Inhalation TherapyOxygen SaturationAdultBurn UnitsCross-Over StudiesFemaleHospital MortalityHumansHypoxiaMaleMiddle AgedTreatment OutcomeOxygencritical illnesshyperoxemiainjurymilitaryOxygenthermal burnwound healing

Identifiers

PMID40604863
PMCPMC12643034

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.