Surgeries Undergoing General Anesthesia
Conditions
Keywords
Intraoperative oxygenation, oxygen, surgery, anesthesia, mechanical ventilation, organ injury, acute kidney injury, myocardial injury, lung injury, stroke, pragmatic, cluster
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.
Detailed description
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.
Interventions
OTHERLower FiO2
FiO₂ 0.21-0.40 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia
OTHERIntermediate FiO2
FiO₂ 0.40-0.80 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia
OTHERHigher FiO2
FiO₂ \> 0.80 to maintain SpO₂ ≥ 94% during maintenance anesthesia
Sponsors
Frederic T Billings IV
Multicenter Perioperative Outcomes Group
University of Michigan
The Association of University Anesthesiologists
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcomes are measured through routine clinical care. The primary statistician is masked to treatment assignments during analysis.
Intervention model description
Cluster randomized, cluster crossover
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient located in a participating operating room * Planned surgery includes tracheal intubation
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composite of organ injury or in-hospital death within 30 days of surgery | 30 days post-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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day mortality | 30 days post-surgery | Death from any cause within 30 days of surgery |
Countries
United States
Contacts
CONTACTTracie Baker, CCRA
PRINCIPAL_INVESTIGATORFrederic T Billings, MD
Vanderbilt University Medical Center
Outcome results
None listed