Evidence map›Paper›PMID 34749762›Full record

ArticleTrials2021

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.

Layne Dylla, David J Douin, Erin L Anderson, John D Rice, Conner L Jackson, Vikhyat S Bebarta, Christopher J Lindsell, Alex C Cheng, Steven G Schauer, Adit A Ginde

2 registry-linked trialsOpen access · goldAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing papers in PubMed
0.9field-weighted citation impact, top 24% of its field
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.

NCT04534959 phase3active not recruitingnot on this map

Strategy to Avoid Excessive Oxygen for Critically Ill Trauma Patients (SAVE-O2)

TypeinterventionalSponsorUniversity of Colorado, DenverRan2020 to 2025Enrolled6,000ConditionsCritical Illness, Wounds and Injury, Disease Attributes, Pathologic ProcessesArmsTargeting Normoxemia (SpO2 90-96%, PaO2 60-100 mmHg)
NCT06501118 narecruitingnot on this mapstarted 2024, after this paper: background citation

Optimizing Care in Critically Ill at UCHealth by Liberalizing the Target O2 in Mechanically-ventilated ICU Patients

TypeinterventionalSponsorUniversity of Colorado, DenverRan2024 to 2026Enrolled3,600ConditionsRespiratory Failure, Acute Hypoxemic Respiratory Failure, Acute Hypoxic Respiratory Failure, HypoxemiaArmsEducation, Epic notification alert
3 · Its place in the literature

Who cites it

9 citing papers in PubMed, 11 citations in OpenAlex.

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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

10 authors at 4 institutions in 1 country.

Layne Dylla *Department of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA.
David J Douin *Department of Anesthesiology, University of Colorado School of Medicine, Aurora, CO, USA.
Erin L AndersonDepartment of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA.
John D RiceDepartment of Biostatistics and Informatics, Colorado School of Public Health, Aurora, CO, USA.
Conner L JacksonDepartment of Biostatistics and Informatics, Colorado School of Public Health, Aurora, CO, USA.
Vikhyat S BebartaDepartment of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA.
Christopher J LindsellDepartment of Biostatistics, Vanderbilt University Medical Center, Nashville, TN, USA.
Alex C ChengDepartment of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, TN, USA.
Steven G SchauerUS Air Force 59th Medical Wing, Office of the Chief Scientist, JBSA, Lackland, San Antonio, TX, USA.
Adit A GindeDepartment of Emergency Medicine, University of Colorado School of Medicine, Aurora, CO, USA. Adit.Ginde@cuanschutz.edu.
University of Colorado Denver · USColorado School of Public Health · USVanderbilt University Medical Center · USUnited States Army Institute of Surgical Research · US

Funding

Anesthesiology Mentored Research TrainingT32GM135169 · NIGMS · UNIVERSITY OF COLORADO DENVER · PI Susan L Ingram, Vesna Jevtovic-Todorovic · 2021 to 2026
$1.0M
Department of Defense/Joint Warfigher Medical Research Program W81XWH-20-2-0001NIGMS NIH HHS T32 GM135169
6 · The paper itself

Abstract

backgroundTargeted normoxia (SpO

methodsDesign, setting, and participants: Protocol for a multicenter cluster randomized, stepped wedge implementation trial evaluating the effectiveness of a multimodal intervention to target normoxia in critically ill trauma patients at eight level 1 trauma centers in the USA. Each hospital will contribute pre-implementation (control) and post-implementation (intervention) data. All sites will begin in the control phase with usual care. When sites reach their randomly assigned time to transition, there will be a one-month training period, which does not contribute to data collection. Following the 1-month training period, the site will remain in the intervention phase for the duration of the trial.

main outcome measuresThe primary outcome will be supplemental oxygen-free days, defined as the number of days alive and not on supplemental oxygen. Secondary outcomes include in-hospital mortality to day 90, hospital-free days to day 90, ventilator-free days (VFD) to day 28, time to room air, Glasgow Outcome Score (GOS), and duration of time receiving supplemental oxygen. DISCUSSION: SAVE-O2 will determine if a multimodal intervention to improve compliance with targeted normoxia will safely reduce the need for concentrated oxygen for critically injured trauma patients. These data will inform military stakeholders regarding oxygen requirements for critically injured warfighters, while reducing logistical burden in prolonged combat casualty care.

trial registrationClinicalTrials.gov NCT04534959 . Registered September 1, 2020.

Indexed as

Critical IllnessHyperoxiaHumansMulticenter Studies as TopicOxygenRandomized Controlled Trials as TopicTreatment OutcomeOxygenCritical careHyperoxiaInjuriesIntensive care unitsOxygenationTrauma

Identifiers

PMID34749762
PMCPMC8574946
OpenAlexW3211964211

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

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.