Oxygen saturation Trials in Disease

Oxygen Therapy to Prevent Breathing Problems After Non-Cardiac Surgery in Patients at Risk for Postoperative Complications

This trial, known as the AIOLOS study, is designed for patients who are at risk for complications after undergoing non-cardiac surgeries, such as general surgery or urological procedures. The study compares two approaches to postoperative care: one group receives supplemental oxygen delivered through a small tube placed in the nose (nasal cannula) at a rate of 3 liters per minute, while the other group receives standard care without additional oxygen.

Who can participate:

• Patients scheduled for elective non-cardiac surgery, including general or urological procedures
• Those who are 60 years of age or older
• Patients with at least one overnight hospital stay planned before surgery and two planned overnight stays after surgery
• Individuals at risk for postoperative complications, identified by factors such as elevated heart-related proteins, history of heart or blood vessel disease, age 75 or older, current or recent smoking, diabetes, high cholesterol, high blood pressure, or irregular heartbeat
• Surgery must be performed under general anesthesia
• Written informed consent must be provided

Who cannot participate:

• Patients who are not considered at risk for postoperative complications
• Those outside the specified age range
• Individuals belonging to vulnerable populations who may require special protection

What the trial involves:

The main goal of this study is to investigate whether providing supplemental oxygen can help reduce the amount of time that blood oxygen levels drop below 90% during the first two days after surgery. Blood oxygen levels are monitored continuously using a simple finger clip device called a pulse oximeter. This device painlessly measures the oxygen saturation in the blood.

Researchers will also assess other important factors, including the quality of recovery on the first day after surgery using a patient questionnaire, the occurrence of confusion or disorientation (delirium) during the first two days, and any surgical site infections that may develop within 30 days of the procedure.

Investigational treatment:

The treatment being tested is oxygen therapy delivered through a nasal cannula at 3 liters per minute. This approach provides a steady flow of oxygen to help maintain adequate oxygen levels in the blood during the recovery period. By increasing the amount of oxygen available in the bloodstream, this therapy supports cellular metabolism and energy production, which are essential for healing after surgery.

The trial is expected to begin recruiting participants in October 2024 and aims to complete enrollment by November 2025. The findings from this study may help improve care for patients recovering from surgery by providing evidence about the benefits of supplemental oxygen therapy in preventing complications related to low oxygen levels.