Feasibility Study to Compare Two Ventilatory Modes for Mechanical Ventilation Weaning

Launched by UNIVERSITY OF LAUSANNE HOSPITALS · Mar 28, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new method to help patients who have been on a breathing machine (mechanical ventilation) recover and breathe on their own again. The researchers want to see if a specific type of ventilation called Bilevel Positive Airway Pressure without synchronization (BIPAPasynchro) can make it easier for patients to transition off the breathing machine compared to the usual method, known as pressure support ventilation (PSV). Before conducting a larger study, this smaller trial will check if the hospital staff can use the new method effectively.

To be eligible for this trial, participants need to be adults aged 18 or older who are currently intubated in the ICU due to severe breathing difficulties. They should have been on a breathing machine for more than 24 hours and their doctors must think they are ready to start the process of breathing on their own again. Unfortunately, certain individuals, such as those with specific serious health issues or very poor prognosis, will not be able to participate. If enrolled, patients can expect to receive close monitoring and care as they try this new approach to help them recover their breathing.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Intubated ICU patient with acute respiratory failure;
• • PaO2-FiO2 ratio of less than 300 mmHg (40 kPa) at least one hour after intubation;
• • control or assist-control ventilation;
• • expected duration of mechanical ventilation of more than 24 hours;
• • clinician in charge considers that the patient can be switched to assisted ventilation (weaning phase start);
• • informed consent obtained by the patient himself / legal representative or authorization received from independent physician
• Exclusion Criteria:
• • less than 18 years old;
• • pregnant women (because of very different respiratory mechanics);
• • severe obesity (BMI \> 40 kg/m2);
• • known obstructive pulmonary disease;
• • expected death within one week or very poor prognosis with end-of-life care decision expected/treatment withdrawal;
• • neurological disorders heavily influencing breathing pattern, like suspected or proven hypoxic brain injury, spinal injury above C8, severe traumatic brain injury, polyneuropathies (ex. Guillain-Barré, myasthenia gravis);
• • home non-invasive ventilation prior to ICU admission, except CPAP for obstructive sleeping apnoea syndrome;
• • tracheostomised at ICU admission;
• • suspected or proven broncho-pleural fistulas;
• • extracorporeal membrane oxygenation (ECMO) treatment;
• • ICU admission for major burns;
• • enrolment in other trial with competitive outcomes or treatment strategies;
• • Known opposition to research participation if patient is not able to consent (eg patient with refused GC)