Invasive Mechanical Ventilation Strategies in Venovenous-Extracorporeal Life Support (IMV-ECLS)
Study Status: Completed
Study Purpose: The goal of this study is to find out which ventilator settings work best for patients with severe lung failure and need a life-support machine called extracorporeal life support (ECLS) to help them breathe.
Background: Every year, about 15 million people around the world, including 100,000 in Canada, become so sick they need a machine to help them to breathe. For very severe cases, doctors will use a special life-support machine called VV-ECLS which takes over the work of the lungs. VV-ECLS removes blood from the body through a tube. The machine adds oxygen to the blood and removes carbon dioxide. Then the clean blood is returned to the body. VV-ECLS can save people’s lives by giving the lungs a chance to rest and heal, but it also comes with serious risks like infections, long hospital stays, and high costs. When someone stays on VV-ECLS for a long time, they are more likely to experience problems.
A key part of care during VV-ECLS is how the ventilator is set. Even though VV-ECLS helps with breathing, the ventilator still affects the lungs. A low pressure setting can cause the lungs to become more stiff, which could slow recovery and increase the risk of infections. A higher pressure setting might help keep the lungs open, reduce inflammation, and improve heart and lung function.
Study Methods: Participants will be randomly assigned to 1 of 3 ventilator strategies:
1. PEEP-10 - Standard low PEEP strategy
• A low pressure setting (PEEP = 10 cm H₂O).
• Used unless higher pressure is absolutely needed to help with breathing.
• This is the comparison group in the study, so researchers can see if the other methods work better.
2. PEEP-20 - Standard high PEEP strategy
• A high-pressure setting (PEEP = 20 cm H₂O).
• Used to see if more pressure helps the lungs recovery more quickly.
3. PEEP-AOP - Individualized PEEP strategy based on AOP
• A customized setting based on each patient’s needs using a special test called AOP.
Patients will receive the intervention until the are extubated early or for 28 days.
Health Conditions: Lungs & Breathing conditions
STIMULUS: A randomized clinical trial of diaphragm pacing in patients on life support for breathing failure
Study Status: Completed
Study Purpose: This study assessed the use of gentle electrical pulses to temporarily stimulate the diaphragm muscle to contract in patients on a breathing machine. The gentle electrical pulses were delivered through a special catheter.
Background: Mechanical ventilation (the 'breathing machine') and sedation are common life-saving methods used to help patients with breathing problems, especially those with lung failure. However, these treatments suppress the patient’s natural breathing rhythm and stop the diaphragm (the main breathing muscle) from contracting. When the diaphragm stops contracting, several problems may rapidly develop. These include diaphragm muscle weakness, poor blood circulation, lung deflation and lung injury. These problems can slow down a patient’s recovery and prolong their need to stay on the “breathing machine”. This also increases their risk of death or long-term disability.
Study Methods: For our study, we equipped 19 patients on mechanical ventilation with a special catheter. The catheter had electrodes that connected directly to the phrenic nerve. Through this catheter, gentle electrical pulses were delivered to the phrenic nerve, to cause the diaphragm muscle to contract in sync with the ventilator.
Key Findings: This was a first in-human trial of this strategy. The diaphragm was successfully stimulated and all patients were kept artificially breathing for as long as they were on the ventilator. Overall, the study procedure was considered safe. The ability to temporarily stimulate the phrenic nerve to keep the diaphragm contracting is a promising strategy. It has the potential to reduce the negative effects of mechanical ventilation on the diaphragm, lungs, and circulation. Studying this for the first time in humans, will lead to future research to test the benefit of this strategy for survival, recovery, and quality of life.
Health Conditions: Lungs & Breathing conditions
RESPIRE: Influence of breathing muscles and limb muscles on long-term survival and quality of life for patients after mechanical ventilation
Study Status: Active
Study Purpose: This study is to understand how the muscles used for breathing in and out, and moving the limbs change over time in patients on mechanical ventilation (‘the breathing machine’). We want to understand how each of these muscle groups affects patients survival. We also want to know how changes in these muscles affect patients’ mental and physical function after leaving the hospital. Understanding more about how mechanical ventilation causes these muscles to weaken, can help us find better ways to help patients recover. This will also help patients move around easier, and stay healthy after leaving the hospital.
Background: Patients on mechanical ventilation are at high risk of losing muscle mass and strength. This affects multiple muscle groups, including the inspiratory muscles (muscles that allow you to inhale air), the expiratory muscles (muscles allow you to exhale air), and limb muscles (muscles allow you to move and walk). Many efforts to help patients recover have focused on strengthening the muscles in their arms and legs, often forgetting about the muscles used for breathing.
Study Methods: We will examine the inspiratory, expiratory, and limb muscles in 200 patients receiving mechanical ventilation. We will use ultrasound (sound waves) to see how these muscles change over time during hospitalization. We will then follow the mental and physical health of these patients for 6 months after they leave the hospital. Lastly, we will collect blood samples to develop a biomarker (blood test) to help doctors to detect and treat muscle injury during mechanical ventilation.
Health Conditions: Lungs & Breathing conditions