Impact of Intraoperative Oxygenation Practices on Patient Outcomes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

54000 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-01

Study Completion Date

2028-04-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Supplemental Perioperative Oxygen to Reduce Surgical Site Infection After High Energy Fracture Surgery

NCT01798810

Post Operative Surgical Site Infection

COMPLETED NA

Oxygen Level and Safe Emergence From Anesthesia

NCT01779076

Focus of Study is Postoperative Pulmonary Atelectacis

COMPLETED NA

Lower Inspiratory Oxygen Fraction for Preoxygenation

NCT03665259

Intraoperative Complications Respiratory Complication Oxygen Toxicity +2 more

TERMINATED NA

Respiratory Effects of Perioperative Oxygen During General Anaesthesia

NCT00637936

Laparotomy

COMPLETED PHASE4

Supplemental Oxygen - Effect on Occurrence of Subsequent Cancer After Abdominal Surgery (Follow-up of the PROXI Trial)

NCT01723280

Laparotomy

COMPLETED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Surgeries Undergoing General Anesthesia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Cluster randomized, cluster crossover

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcomes are measured through routine clinical care. The primary statistician is masked to treatment assignments during analysis.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Lower FiO2

Group Type EXPERIMENTAL

Lower FiO2

Intervention Type OTHER

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

Intermediate FiO2

Group Type EXPERIMENTAL

Intermediate FiO2

Intervention Type OTHER

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

Higher FiO2

Group Type EXPERIMENTAL

Higher FiO2

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Lower FiO2

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

Intervention Type OTHER

Intermediate FiO2

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

Intervention Type OTHER

Higher FiO2

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No