Impact of Intraoperative Oxygenation Practices on Patient Outcomes

NCT07224243 | Recruiting DMC

• 1 other identifier: 241806
• Study Type: interventional
• Target: 54,000
• Locations: 1 country
• Sites: 1

Brief Summary

This multicenter, cluster-randomized, cluster-crossover clinical trial evaluates the impact of three intraoperative FiO2 (Fraction of Inspired Oxygen) oxygenation strategies-lower (FiO₂ 0.21-0.40), intermediate (FiO₂ 0.40-0.80), and higher (FiO₂ 0.80-1.00)-on postoperative organ injury and mortality in adult surgical patients. The trial aims to determine the optimal oxygenation strategy to improve perioperative outcomes.

Conditions

Surgeries Undergoing General Anesthesia

Keywords

Intraoperative oxygenation; oxygen; surgery; anesthesia; mechanical ventilation; organ injury; acute kidney injury; myocardial injury; lung injury; stroke; pragmatic; cluster

Outcome Measures

Primary Outcomes (1)

• Composite of organ injury or in-hospital death within 30 days of surgery

  This composite outcome measures the number of participants experiencing at least one of the following organ injuries or death within the defined study period: * Acute Kidney Injury (AKI), defined according to creatinine based Kidney Disease Improving Global Outcomes criteria, specifically a 0.3 mg/dL or greater increase within 48 hours or a 50% or greater increase from baseline within seven days of surgery. * Myocardial injury, defined as \>99th percentile of normal based on site-specific troponin assay within 72 hours of surgery. * Lung injury, defined using international classification of diseases, ninth revision or tenth revision (ICD-9 or ICD-10) diagnosis codes * Stroke, defined using international classification of diseases, ninth revision or tenth revision (ICD-9 or ICD-10) diagnosis codes * Death within 30 days of surgery

  30 days post-surgery

Secondary Outcomes (1)

• 30-day mortality

  30 days post-surgery

Other Outcomes (7)

• Acute kidney injury

  7 days post-surgery

• Myocardial injury

  72 hours post-surgery

• Lung injury

  30 days post-surgery

Study Arms (3)

Lower FiO2

EXPERIMENTAL

Other: Lower FiO2

Intermediate FiO2

EXPERIMENTAL

Other: Intermediate FiO2

Higher FiO2

EXPERIMENTAL

Other: Higher FiO2

Interventions

Lower FiO2 OTHER

FiO₂ 0.21-0.40 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia

Lower FiO2

Intermediate FiO2 OTHER

FiO₂ 0.40-0.80 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia

Intermediate FiO2

Higher FiO2 OTHER

FiO₂ \> 0.80 to maintain SpO₂ ≥ 94% during maintenance anesthesia

Higher FiO2

Eligibility Criteria

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

You may qualify if:

• Patient located in a participating operating room
• Planned surgery includes tracheal intubation

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 American Society of Anesthesiologists (ASA) classification-6 (i.e., organ donor)
• Patient's planned surgical case includes open heart surgery, defined as surgery on the heart or ascending aorta requiring sternotomy or thoracotomy.
• Patient's planned procedure requires prolonged apnea, bronchoscopy, airway surgery, or one-lung ventilation.
• Patient's planned surgical case includes use of extracorporeal membrane oxygenation (ECMO).
• Patient is known to have a history of bleomycin treatment.
• Patient was enrolled in the trial in the prior 30 days.

Sponsors & Collaborators

• Frederic T Billings IV: lead
• Multicenter Perioperative Outcomes Group: collaborator
• University of Michigan: collaborator
• The Association of University Anesthesiologists: collaborator

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Lung Injury; Stroke

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lung Diseases; Respiratory Tract Diseases; Thoracic Injuries; Wounds and Injuries; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Frederic T Billings, MD

  Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tracie Baker, CCRA

CONTACT

6158751852; tracie.d.baker@vumc.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes are measured through routine clinical care. The primary statistician is masked to treatment assignments during analysis.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Anesthesiology

Model Details: Cluster randomized, cluster crossover

Study Record Dates

• First Submitted: October 31, 2025
• First Posted: November 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): February 1, 2028
• Study Completion (Estimated): April 1, 2028
• Last Updated: December 3, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)