Ongoing Clinical Trials for Postoperative Oxygen Therapy
This article provides information about a current clinical trial investigating oxygen therapy to prevent breathing problems after non-cardiac surgery in patients at risk for complications. The trial is examining whether providing supplemental oxygen can help reduce temporary drops in blood oxygen levels during recovery from general or urological surgery.
Clinical trial locations
Oxygen Therapy to Prevent Breathing Problems After Non-Cardiac Surgery in Patients at Risk for Postoperative Complications
This trial, known as the AIOLOS trial, is being conducted in Austria and focuses on patients who face a higher risk of complications following non-cardiac surgeries such as general or urological procedures. The study aims to determine whether providing supplemental oxygen through a simple nasal tube after surgery can help prevent temporary drops in blood oxygen levels.
Main inclusion criteria:
- Patients scheduled for elective non-cardiac surgery, including general surgery or urological procedures
- Must be 60 years of age or older
- At least one overnight stay before surgery and two planned overnight stays after surgery
- Must be at risk for postoperative complications, defined by at least one of the following: elevated heart-related protein levels before surgery, history of coronary or peripheral artery disease, age 75 or older, history of stroke or mini-stroke, current or recent smoking, diabetes, high cholesterol, high blood pressure, or irregular heartbeat
- Surgery must be performed under general anesthesia
- Must provide written informed consent to participate
Main exclusion criteria:
- Patients who are not at risk for postoperative complications after general or urological surgery
- Patients outside the specified age range
- Patients who belong to vulnerable populations that require special protection
Focus and goals:
The trial compares two groups of patients. Group A receives oxygen at a flow rate of 3 liters per minute through a nasal cannula, while Group B receives standard postoperative care without additional oxygen. The main goal is to measure the average time that patients’ blood oxygen levels fall below 90% during the first two days after surgery. This is monitored using a pulse oximeter, a simple device that clips onto a finger to measure oxygen levels in the blood.
Additional assessments include evaluating the quality of recovery on the first day after surgery using a questionnaire, checking for the occurrence of delirium during the first two days, and documenting any surgical site infections within 30 days through hospital records and a follow-up phone call.
Investigational treatment:
The study is investigating oxygen therapy delivered through a nasal cannula at 3 liters per minute. This treatment increases the amount of oxygen available in the bloodstream, which is essential for cellular metabolism and energy production. The therapy is being tested to see if it can effectively prevent postoperative complications related to low oxygen levels.
The trial is expected to begin recruiting participants in October 2024 and conclude by November 2025. The results could help improve recovery care for surgical patients by providing evidence about the benefits of supplemental oxygen therapy after surgery.
Summary
Currently, there is one clinical trial actively investigating oxygen therapy for preventing breathing problems after non-cardiac surgery. The trial is taking place in Austria and focuses specifically on patients aged 60 and older who are at increased risk for postoperative complications. The study examines oxygen therapy as a respiratory support treatment, delivered at a modest flow rate through a nasal cannula. The research aims to provide clear evidence on whether this simple intervention can meaningfully reduce temporary drops in blood oxygen levels during the critical first two days after surgery, potentially improving recovery outcomes for vulnerable surgical patients.
