Effects of PERMISSive Lung-protective Ventilation on Outcome in Critically Ill Invasively Ventilated Patients

Launched by REINIER DE GRAAF GROEP · Jul 11, 2025

Keywords

ClinConnect Summary

This clinical trial is exploring a new way to help critically ill patients who need a breathing machine (ventilator) because their lungs aren’t working well due to low oxygen levels. The study is testing a method called "permissive lung-protective ventilation," which uses a slower breathing rate on the ventilator. This approach may reduce the stress on the lungs but can cause a build-up of carbon dioxide in the blood, which doctors call “permissive hypercapnia.” The main goal is to see if this slower breathing strategy is safe and workable before testing it in a larger group of patients.

Adults who are very sick, have been placed on a ventilator due to low oxygen in their blood, and are expected to need the ventilator for more than one day may be eligible to join. Patients must have started ventilation within the last hour to participate. Those with certain other health problems or who are receiving other advanced life support treatments won’t be included. If you join, you will be randomly assigned to either the new slower breathing rate method or the usual ventilator settings. Doctors will carefully monitor your breathing, oxygen levels, and carbon dioxide levels to ensure safety. This study involves no extra risky procedures beyond standard care, and any blood tests done are part of regular treatment. The results will help doctors understand whether this gentler ventilator approach can be safely used more widely in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • admission to one of the participating ICUs;
• • intubated and receiving invasive ventilation for acute hypoxemic respiratory failure;
• • expected duration of ventilation of at least 24 hours and
• • receiving invasive ventilation ≤ 1 hour.
• Exclusion Criteria:
• • age below 18 years;
• • intubated and receiving invasive ventilation for other reasons than acute hypoxemic respiratory failure;
• • receiving or planned to receive veno-venous, veno-arterial or arterio-venous extracorporeal membrane oxygenation (ECMO);
• • having COPD GOLD III and IV;
• • contra-indication for hypercapnia, such as ongoing cardiac ischemia (as defined in the guideline of the European Society of Cardiology), or having suspected or confirmed increased intracranial pressure due to brain injury, judged by the attending physician;
• • having metabolic acidosis, with a pH \< 7.20 and judged by the attending physician to have a metabolic cause;
• • after cardiac resuscitation;
• • any neurologic diagnosis that can prolong duration of mechanical ventilation, e.g., Guillain-Barré syndrome, high spinal cord lesion or amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis;
• • suspected or confirmed pregnancy;
• • participation in another interventional trial using similar endpoints;
• • previously randomized in this study;
• • no informed consent; or
• • admitted for terminal care