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Recruiting NCT07224243

Impact of Intraoperative Oxygenation Practices on Patient Outcomes

No phase Interventional Surgeries Undergoing General Anesthesia

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Lower FiO2, Intermediate FiO2, Higher FiO2.
Who it may be relevant to
Registry conditions: Surgeries Undergoing General Anesthesia. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

  • Other Lower FiO2
    FiO₂ 0.21-0.40 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia
  • Other Intermediate FiO2
    FiO₂ 0.40-0.80 or lowest FiO₂ to maintain SpO₂ ≥ 94% during maintenance anesthesia
  • Other Higher FiO2
    FiO₂ \> 0.80 to maintain SpO₂ ≥ 94% during maintenance anesthesia

Primary outcome measures

  • Composite of organ injury or in-hospital death within 30 days of surgery [Time frame: 30 days post-surgery]
Secondary outcome measures (1)
  • 30-day mortality [Time frame: 30 days post-surgery]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Crossover
Masking
Single blind
Primary purpose
Treatment

Study locations

United States · 4 centers
  • University of Michigan Hospital — Ann Arbor
  • Nebraska Medical Center — Omaha
  • Vanderbilt University Medical Center — Nashville
  • University of Utah Huntsman Cancer Institute — Salt Lake City

Identifiers

NCT: NCT07224243 · 241806

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗