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.
The Intraop Ox trial will enroll adult patients undergoing surgery with tracheal intubation. Participating hospitals will be randomly assigned (as a unit) to administer one of three oxygenation strategies during maintenance anesthesia (lower FiO₂ \[0.21-0.40\], intermediate FiO₂ \[0.40-0.80\], or higher \[FiO₂ 0.80-1.00\] each period (month). The primary outcome is a composite of organ injury (acute kidney injury, myocardial injury, lung injury, stroke) or death within 30 days. Secondary outcome is 30-day mortality. Exploratory outcomes are individual components of the composite primary endpoint, surgical site infection, length of stay, and hypoxemia. The study is conducted under a waiver of informed consent due to minimal incremental risk of participating and impracticability of obtaining consent in this cluster-randomized design.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
54,000
FiO₂ 0.21-0.40 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia
FiO₂ 0.40-0.80 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia
FiO₂ \> 0.80 to maintain SpO₂ ≥ 94% during maintenance anesthesia
University of Michigan Hospital
Ann Arbor, Michigan, United States
NOT_YET_RECRUITINGNebraska Medical Center
Omaha, Nebraska, United States
NOT_YET_RECRUITINGVanderbilt University Medical Center
Nashville, Tennessee, United States
RECRUITINGComposite 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
Time frame: 30 days post-surgery
30-day mortality
Death from any cause within 30 days of surgery
Time frame: 30 days post-surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
University of Utah Huntsman Cancer Institute
Salt Lake City, Utah, United States
NOT_YET_RECRUITING