Evidence map›Paper›PMID 41605593›Full record

ArticleBMJ open2026

Statistical analysis plan for the Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention (SAVE-O2 AI) trial: protocol.

David J Douin, John D Rice, Mengli Xiao, Laurel Beaty, Claire Guo, Cori Withers, Amy Sullivan, Erin L Anderson, Alex C Cheng, Mary K Banasiewicz and 12 more

2 registry-linked trialsAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in BMJ open, 2026. 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. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing 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.

NCT06374225 nacompletednot on this map

Strategy to Avoid Excessive Oxygen Using an Autonomous Oxygen Titration Intervention (SAVE-O2 AI)

TypeinterventionalSponsorUniversity of Colorado, DenverRan2024 to 2026Enrolled300ConditionsCritical Illness, Wounds and Injury, Disease Attributes, Pathologic ProcessesArmsAutomated Titration (O2matic)
NCT07576946 active not recruitingnot on this map

Development and Pilot Evaluation of an Artificial Intelligence-Assisted System for Automated Oxygen Flow Regulation: The Saturista Device

TypeobservationalSponsorKoç UniversityRan2026 to 2026Enrolled7ConditionsOxygen Therapy
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

22 authors.

David J DouinDepartment of Anesthesiology, University of Colorado School of Medicine, Aurora, Colorado, USA David.Douin@cuanschutz.edu.ORCID http://orcid.org/0000-0002-5215-6854
John D RiceDepartment of Biostatistics, University of Michigan School of Public Health, Ann Arbor, Michigan, USA.
Mengli XiaoDepartment of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA.
Laurel BeatyDepartment of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA.ORCID http://orcid.org/0000-0001-8021-7872
Claire GuoDepartment of Biostatistics and Informatics, Colorado School of Public Health, Aurora, Colorado, USA.
Cori WithersDepartment of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.
Amy SullivanDepartment of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.
Erin L AndersonDepartment of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.
Alex C ChengDepartment of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Mary K BanasiewiczDepartment of Biomedical Informatics, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Matthew W SemlerDepartment of Medicine, Division of Allergy, Pulmonary and Critical Care Medicine, Vanderbilt University Medical Center, Nashville, Tennessee, USA.ORCID http://orcid.org/0000-0002-7664-8263
Bradley Daniel LloydVanderbilt Institute for Clinical and Translational Research, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
Amelia MaigaDivision of Acute Care Surgery, Department of Surgery, Vanderbilt University Medical Center, Nashville, Tennessee, USA.ORCID http://orcid.org/0000-0001-6488-7024
Kevin W GibbsSection of Pulmonary, Critical Care, Allergy, and Immunologic Disease, Department of Medicine, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
Gregory R StettlerDepartment of Surgery, Wake Forest School of Medicine, Winston-Salem, North Carolina, USA.
Akram KhanDepartment of Medicine, Division of Pulmonary and Critical Care Medicine, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.
Mitchell B SallyDepartment of Surgery, Oregon Health & Science University School of Medicine, Portland, Oregon, USA.
Franklin L WrightDepartment of Surgery, University of Colorado School of Medicine, Aurora, Colorado, USA.
Neil AggarwalDepartment of Medicine, Division of Pulmonary Sciences and Critical Care Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.
Vikhyat S BebartaDepartment of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.
Adit A GindeDepartment of Emergency Medicine, University of Colorado School of Medicine, Aurora, Colorado, USA.
SAVE-O2 AI Investigators

Funding

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 R03 HL178873
6 · The paper itself

Abstract

introductionAdministering supplemental oxygen to prevent hypoxaemia is a fundamental treatment for patients hospitalised with acute injury or illness. However, the amount of oxygen administered frequently exceeds that needed to maintain normoxaemia, causing patients to experience hyperoxaemia and wasting supplemental oxygen. Closed-loop, autonomous oxygen titration systems are designed to optimise oxygen delivery by administering the lowest possible oxygen flow that maintains peripheral oxygen saturation (SpO₂) within a predefined range. For adults hospitalised with an acute injury or illness, it remains uncertain whether the use of a closed-loop, autonomous oxygen titration system safely increases the proportion of time spent in normoxaemia (SpO METHODS AND ANALYSIS: The Strategy to Avoid Excessive Oxygen using Autonomous Oxygen Titration Intervention trial is a multicentre, unblinded, parallel-group, randomised trial being conducted at four level 1 trauma centres in the USA. The trial compares an autonomous oxygen titration system versus usual care among 300 adults hospitalised for major trauma, burn, acute care surgery or acute respiratory illness. The primary outcome is the proportion of patient-time spent within the targeted normoxaemia range (SpO ETHICS AND DISSEMINATION: The trial protocol was approved by the single institutional review board at the University of Colorado School of Medicine and the Office of Human Research Oversight at the Department of Defense. We will present the results at scientific conferences and submit them for publication in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NCT06374225.

Indexed as

HypoxiaOxygenOxygen Inhalation TherapyAdultData Interpretation, StatisticalHumansMulticenter Studies as TopicOximetryOxygen SaturationRandomized Controlled Trials as TopicResearch DesignWounds and InjuriesOxygenHyperoxiaHypoxiaINTENSIVE & CRITICAL CAREOxygen Saturation

Identifiers

PMID41605593
PMCPMC12853544

What OpenQuestion holds

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LicenceCC BY-NC
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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.