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| Name | Class |
|---|---|
| Multicenter Perioperative Outcomes Group | OTHER |
| University of Michigan | OTHER |
| The Association of University Anesthesiologists | UNKNOWN |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower FiO2 | Experimental |
| |
| Intermediate FiO2 | Experimental |
| |
| Higher FiO2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lower FiO2 | Other | FiO₂ 0.21-0.40 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| 30 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day mortality | Death from any cause within 30 days of surgery | 30 days post-surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Acute kidney injury | Incidence of acute kidney injury (AKI), defined according to creatinine based Kidney Disease Improving Global Outcomes criteria, specifically a 0.3 mg/dL or greater increase from baseline within 48 hours or a 50% or greater increase from baseline within seven days of surgery | 7 days post-surgery |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tracie Baker, CCRA | Contact | 6158751852 | tracie.d.baker@vumc.org |
| Name | Affiliation | Role |
|---|---|---|
| Frederic T Billings, MD | Vanderbilt University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Michigan Hospital | Not yet recruiting | Ann Arbor | Michigan | 48109 | United States |
Individual participant data cannot be removed from the MPOG servers where they are stored and analysed. We will review requests for data analyses that use individual patient data, but it would have to be performed inside these servers - i.e., IPD cannot not be shared with others.
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| ID | Term |
|---|---|
| D058186 | Acute Kidney Injury |
| D055370 | Lung Injury |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Cluster randomized, cluster crossover
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Outcomes are measured through routine clinical care. The primary statistician is masked to treatment assignments during analysis.
| Intermediate FiO2 | Other | FiO₂ 0.40-0.80 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia |
|
| Higher FiO2 | Other | FiO₂ > 0.80 to maintain SpO₂ ≥ 94% during maintenance anesthesia |
|
| Myocardial injury |
Myocardial injury, defined as >99th percentile of normal plasma troponin based on site-specific troponin assay within 72 hours of surgery. |
| 72 hours post-surgery |
| Lung injury | Lung injury, defined using international classification of diseases, ninth revision or tenth revision (ICD-9 or ICD-10) diagnosis codes | 30 days post-surgery |
| Stroke | Stroke, defined using international classification of diseases, ninth revision or tenth revision (ICD-9 or ICD-10) diagnosis codes | 30 days post-surgery |
| Surgical site infection | Surgical site infection, defined using National Surgical Quality Improvement Program (NSQIP) criteria and reported to NSQIP and also captured using international classification of diseases (ICD) diagnosis data. | 30 days post-surgery |
| Hospital length of stay | Total number of calendar days from the date of surgery to the date of discharge following the index procedure. | Day of hospital discharge |
| Hypoxemia | Incidence and duration of SpO₂ values < 80% (in minutes) during maintenance anesthesia (from anesthesia induction to anesthesia emergence). | Perioperative |
| Nebraska Medical Center | Recruiting | Omaha | Nebraska | 68105 | United States |
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| Vanderbilt University Medical Center | Recruiting | Nashville | Tennessee | 37212 | United States |
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| University of Utah Huntsman Cancer Institute | Recruiting | Salt Lake City | Utah | 84112 | United States |
|
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D013898 | Thoracic Injuries |
| D014947 | Wounds and Injuries |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |