Intraoperative Oxygenation for Surgery
(IntraOp Ox Trial)
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.12345Why 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?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo surgery with one of three intraoperative FiO2 oxygenation strategies during maintenance anesthesia
Follow-up
Participants are monitored for organ injury and mortality outcomes post-surgery
Extension
Additional monitoring for secondary and exploratory outcomes such as surgical site infection and hospital length of stay
What Are the Treatments Tested in This Trial?
Interventions
- Intraoperative Oxygenation Practices
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
The Association of University Anesthesiologists
Collaborator