Weaning failure Trials in Disease

Study Comparing Non-Invasive Ventilation and High Flow Oxygen Therapy for Patients at Risk of Breathing Support Failure After Ventilator Removal

This trial is focused on patients who face a high risk of experiencing breathing difficulties after being taken off a breathing machine, a process known as extubation. The study compares two different methods that help these patients breathe more easily without needing to be put back on a ventilator.

Who can participate:

• Patients who are 65 years or older
• Those with chronic obstructive pulmonary disease (COPD) or asthma
• Patients who have been on a breathing machine for more than 7 days
• Those with hypercapnia (high carbon dioxide levels in the blood, specifically above 45 mmHg)
• Patients with an ineffective cough or producing a lot of mucus
• Those with a body mass index (BMI) greater than 30
• Patients with cardiac failure or a history of poor heart function
• Those with an APACHE II score greater than 12, which measures illness severity
• Patients experiencing difficult or prolonged weaning from the ventilator
• Those with pneumonia or other medical conditions causing acute respiratory failure

Who cannot participate:

• Patients who are not currently on a mechanical ventilator
• Those who have already been successfully extubated
• Patients outside the specified age range
• Those who belong to vulnerable populations requiring special protection

Main focus of the trial:

The study aims to find out which breathing support method is more effective in preventing the need to put patients back on a ventilator. Researchers will observe patients for signs of breathing problems within 48 hours after the breathing tube is removed. They will also track other important outcomes such as infections acquired in the hospital, the need for a surgical opening in the windpipe (tracheotomy), organ failure, and survival rates both in the intensive care unit and the hospital. The duration of ICU and hospital stays, as well as how long patients need mechanical ventilation, will also be recorded.

Treatments being tested:

The trial is comparing two approaches:

• Non-Invasive Ventilation (NIV): This method uses a mask to support breathing without needing a tube inserted into the windpipe. It provides air or oxygen to the lungs, helping reduce the effort needed to breathe.
• High Flow Oxygen Therapy: This treatment delivers a high flow of oxygen through a small tube placed in the nostrils (nasal cannula). The oxygen used is medicinal grade (99.5% concentration) and is stored at very low temperatures. This therapy provides more oxygen than standard methods and helps keep the airways open, making breathing easier.

Patients joining the study will be randomly assigned to one of these two treatment groups. Throughout the trial, their condition will be closely monitored to see which method works better in supporting recovery and preventing complications.

Summary

Currently, there is one active clinical trial addressing the challenges patients face when being weaned off mechanical ventilation. This trial is taking place in Spain and is scheduled to continue until September 2027. The study focuses on comparing two established breathing support methods—Non-Invasive Ventilation and High Flow Oxygen Therapy—to determine which is more effective in preventing breathing failure after extubation in high-risk patients. The trial specifically targets older patients (65 years and above) with various risk factors such as COPD, cardiac failure, obesity, and prolonged ventilation needs. By examining outcomes such as re-intubation rates, hospital-acquired infections, and mortality, this research aims to improve care strategies for vulnerable patients during the critical transition period after being removed from a ventilator.