Examination of Personalized SpO2 Targets

NCT07536984 | Not Yet Recruiting DMC

• 2 other identifiers: 2412091R61HL180352-01
• Study Type: interventional
• Target: 3,000
• Locations: 1 country
• Sites: 1

Brief Summary

Mechanical ventilation involves titrating the fraction of inspired oxygen to maintain arterial oxygen saturation (SpO2). The SpO2 target that results in the best outcomes for critically ill adults has historically been unknown. Randomized trials comparing use of a higher SpO2 target (96-100%) vs a lower SpO2 target (88-92%) have not found an average treatment effect among patients overall. However, the optimal SpO2 target may differ for patients with different characteristics. Recently, data from randomized trials of SpO2 targets were used to derive and validate a statistical model that predicts which SpO2 target will result in the best outcomes for an individual patient based on his or her unique characteristics (personalized SpO2 target). This statistical model has been incorporated into the electronic health record at Vanderbilt such that, for each patient receiving mechanical ventilation in the medical intensive care unit, information on which SpO2 target is predicted to result in the best outcome for the patient can be made available to clinicians. However, the use of personalized SpO2 targets for critically ill adults receiving mechanical ventilation has never been examined in a randomized trial and whether using such a personalized SpO2 target in clinical care can improve patient outcomes remains unknown. This randomized trial will examine the effect of using information on the SpO2 target that is predicted to be best for a patient based on his or her unique characteristics (personalized SpO2 target) versus usual care.

Conditions

Acute Respiratory Failure

Keywords

Critical illness; Emergency airway management; Mechanical ventilation; Predictive model; Personalized medicine

Outcome Measures

Primary Outcomes (1)

• 28-day in-hospital mortality

  Death from any cause by day 28

  From randomization to the first of hospital discharge or 28 days after randomization

Secondary Outcomes (1)

• Ventilator-free days to day 28

  From randomization to the first of hospital discharge or 28 days after randomization

Study Arms (2)

Personalized SpO2 Target Group

ACTIVE COMPARATOR

For patients in the personalized SpO2 target group, the statistical model within the electronic health record will use each patient's baseline characteristics to calculate the SpO2 target predicted to result in the best outcomes for that individual patient, either 98% (range, 96-100%) for patients predicted to benefit from a higher SpO2 target or 90% (range, 88-92%) for patients predicted to benefit from a lower SpO2 target. The personalized SpO2 target predicted to result in the best outcomes for a patient will be delivered by the physicians, nurses, and respiratory therapists as a part of routine clinical care.

Other: Personalized SpO2 Target

Usual Care Group

ACTIVE COMPARATOR

For patients in the usual care group, clinicians will determine the approach to supplemental oxygen administration without receiving information from the statistical model.

Other: Usual Care

Interventions

Personalized SpO2 Target OTHER

A personalized SpO2 target predicted to result in the best outcomes for a patient will be delivered by the physicians, nurses, and respiratory therapists as a part of routine clinical care.

Personalized SpO2 Target Group

Usual Care OTHER

Clinicians will determine the approach to supplemental oxygen administration without receiving information from the statistical model

Usual Care Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient is located in a participating unit
• Patient is receiving invasive mechanical ventilation

You may not qualify if:

• Patient is known to be less than 18 years old
• Patient is known to be pregnant
• Patient is known to be a prisoner
• Patient is receiving extracorporeal membrane oxygenation
• Clinician has determined that a specific approach to oxygen therapy is required or contraindicated for the optimal care of the patient

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Related Publications (3)

• Semler MW, Casey JD, Lloyd BD, Hastings PG, Hays MA, Stollings JL, Buell KG, Brems JH, Qian ET, Seitz KP, Wang L, Lindsell CJ, Freundlich RE, Wanderer JP, Han JH, Bernard GR, Self WH, Rice TW; PILOT Investigators and the Pragmatic Critical Care Research Group. Oxygen-Saturation Targets for Critically Ill Adults Receiving Mechanical Ventilation. N Engl J Med. 2022 Nov 10;387(19):1759-1769. doi: 10.1056/NEJMoa2208415. Epub 2022 Oct 24.

  PMID: 36278971 BACKGROUND

• Buell KG, Spicer AB, Casey JD, Seitz KP, Qian ET, Graham Linck EJ, Self WH, Rice TW, Sinha P, Young PJ, Semler MW, Churpek MM. Individualized Treatment Effects of Oxygen Targets in Mechanically Ventilated Critically Ill Adults. JAMA. 2024 Apr 9;331(14):1195-1204. doi: 10.1001/jama.2024.2933.

  PMID: 38501205 BACKGROUND

• ICU-ROX Investigators and the Australian and New Zealand Intensive Care Society Clinical Trials Group; Mackle D, Bellomo R, Bailey M, Beasley R, Deane A, Eastwood G, Finfer S, Freebairn R, King V, Linke N, Litton E, McArthur C, McGuinness S, Panwar R, Young P; ICU-ROX Investigators the Australian and New Zealand Intensive Care Society Clinical Trials Group. Conservative Oxygen Therapy during Mechanical Ventilation in the ICU. N Engl J Med. 2020 Mar 12;382(11):989-998. doi: 10.1056/NEJMoa1903297. Epub 2019 Oct 14.

  PMID: 31613432 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Matthew W Semler, MD, MSCI

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Adam Wright, PhD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

• Jonathan D Casey, MD, MSCI

  Vanderbilt University Medical Center

  STUDY DIRECTOR

• Edward T Qian, MD, MSACI

  Vanderbilt University Medical Center

  STUDY CHAIR

Central Study Contacts

Matthew W Semler, MD, MSCI

CONTACT

615-933-6994; matthew.w.semler@vumc.org

Jonathan D Casey, MD, MSCI

CONTACT

615-875-4681; jonathan.d.casey@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: April 12, 2026
• First Posted: April 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2029
• Study Completion (Estimated): January 1, 2030
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Following publication. No end date

Locations

US (1)