Intraoperative Oxygenation for Surgery

(IntraOp Ox Trial)

TB
Overseen ByTracie Baker, CCRA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Frederic T Billings IV
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how varying oxygen levels during surgery affect recovery and the risk of organ injury post-operation. It tests three oxygen strategies: lower, intermediate, and higher levels administered to patients under anesthesia. The goal is to determine which level aids recovery most effectively. It suits adults undergoing surgery that requires a breathing tube. As an unphased trial, this study provides a unique opportunity to contribute to important research that could enhance surgical outcomes for future patients.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these intraoperative oxygenation strategies are safe?

Research has shown that the amount of oxygen given during surgery can affect patient recovery. Lower oxygen levels (FiO2 0.21-0.40) might help prevent lung collapse but could increase other risks. Studies have found that higher oxygen levels (FiO2 0.80-1.00) might cause lung issues post-surgery, although some research suggests no significant harm from using more oxygen. Intermediate oxygen levels (FiO2 0.40-0.80) appear safe, without leading to serious problems like ICU admissions or deaths.

In summary, each oxygen level has its pros and cons. Lower levels might help avoid lung collapse, while higher levels could risk lung problems. Intermediate levels seem safe without causing serious harm.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores different oxygenation practices during surgery, which could significantly impact patient outcomes. Unlike traditional methods that often use a standardized oxygen level, this trial investigates varying oxygen concentrations, specifically lower, intermediate, and higher fractions of inspired oxygen (FiO2). By understanding how different oxygen levels affect surgical patients, this research could pave the way for more personalized and potentially safer anesthesia protocols. This approach might reduce complications related to excessive or insufficient oxygenation, optimizing recovery and improving overall surgical success.

What evidence suggests that this trial's intraoperative oxygenation strategies could be effective for improving perioperative outcomes?

This trial will compare different intraoperative oxygenation practices—specifically lower, intermediate, and higher FiO2 levels—to determine their effects on health outcomes after surgery. Research has shown that the amount of oxygen given during surgery can affect health outcomes afterward. Studies have found that higher oxygen levels can reduce the risk of infections at the surgery site but might cause lung problems. Conversely, lower oxygen levels can decrease the chance of lung issues but might increase the risk of infection. Moderate oxygen levels fall between these two and may help balance the benefits and risks. The optimal oxygen level might depend on the type of surgery and the patient's health.13467

Who Is on the Research Team?

FT

Frederic T Billings, MD

Principal Investigator

Vanderbilt University Medical Center

Are You a Good Fit for This Trial?

This trial is for adult surgical patients. It's looking at how different oxygen levels given during surgery might affect recovery and the chances of problems like kidney failure, lung injury, or stroke after the operation.

Inclusion Criteria

Patient located in a participating operating room
My upcoming surgery will involve a breathing tube.

Exclusion Criteria

Patient is known to be a prisoner
Patient is known to be pregnant
Patient is American Society of Anesthesiologists (ASA) classification-6 (i.e., organ donor)
See 6 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo surgery with one of three intraoperative FiO2 oxygenation strategies during maintenance anesthesia

Perioperative
1 visit (in-person)

Follow-up

Participants are monitored for organ injury and mortality outcomes post-surgery

30 days

Extension

Additional monitoring for secondary and exploratory outcomes such as surgical site infection and hospital length of stay

30 days

What Are the Treatments Tested in This Trial?

Interventions

  • Intraoperative Oxygenation Practices
Trial Overview The study compares three ways to give oxygen during surgery: a lower amount (21-40% oxygen), an intermediate amount (40-80%), and a higher amount (80-100%). Researchers want to see which method is best for preventing organ damage and death after surgery.
How Is the Trial Designed?
3Treatment groups
Experimental Treatment
Group I: Lower FiO2Experimental Treatment1 Intervention
Group II: Intermediate FiO2Experimental Treatment1 Intervention
Group III: Higher FiO2Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Frederic T Billings IV

Lead Sponsor

Multicenter Perioperative Outcomes Group

Collaborator

University of Michigan

Collaborator

Trials
1,891
Recruited
6,458,000+

The Association of University Anesthesiologists

Collaborator

Citations

The effects of high perioperative inspiratory oxygen fraction for ...A high fraction of supplemental inspired oxygen during anaesthesia may decrease or increase mortality and surgical site infections in surgical patients.
The effect of high perioperative inspiratory oxygen fraction ...Our pooled analysis revealed that the application of high FiO 2 reduced the incidence of SSI after abdominal operations.
Higher fraction of inspired oxygen during anesthesia ...High intraoperative FiO 2 (>60%) was associated with the postoperative occurrence of pulmonary complications, independent of predefined risk factors, in ...
Impact of Intraoperative Oxygenation Practices on Patient ...The primary outcome is a composite of organ injury (acute kidney injury, myocardial injury, lung injury, stroke) or death within 30 days.
Perioperative oxygen therapy: an overview of systematic ...Effects of intraoperative high versus low inspiratory oxygen fraction (FiO2) on patient's outcome: a systematic review of evidence from the last 20 years.
Safety of 80% vs 30–35% fraction of inspired oxygen in ...This systematic review and meta-analysis of 17 RCTs did not find robust evidence that perioperative 80% FiO2 is associated with a significant risk of harm ...
High intraoperative inspiratory oxygen fraction and risk ...The primary analysis included 73 922 cases, of whom 3035 (4.1%) developed a major respiratory complication within 7 days of surgery. For patients in the high- ...
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