Permissive lung-protective ventilation in invasively ventilated adults

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this international, multicenter trial, critically ill adults on invasive ventilation are randomized to either a permissive lung-protective strategy with a lower respiratory rate or to conventional lung-protective ventilation. The goal is to see if reducing ventilatory intensity can increase days alive and free from ventilation by day 28. The trial follows 28-day outcomes, with predefined safety limits for the lowest allowable respiratory rate. Participants are adults in ICUs expected to require ventilation for at least 24 hours; several common contraindications to permissive hypercapnia are excluded. The study uses a superiority framework to determine whether the lower RR approach improves patient-centered outcomes compared with standard care.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* admission to one of the participating intensive care units (ICUs);
* intubated and receiving invasive ventilation; and
* expected duration of ventilation of at least 24 hours (based on ICU admission diagnosis and clinical judgment).

Exclusion Criteria:

* age below 18 years;
* invasive ventilation before randomization \> 2 hours in the ICU or invasive ventilation \> 6 hours in the operating room or emergency department directly preceding the current ICU admission;
* receiving or planned to receive veno-venous, veno-arterial or arterio-venous extracorporeal membrane oxygenation (ECMO);
* contraindications 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 (traumatic) brain injury, judged by the attending physician;
* having severe Chronic Obstructive Pulmonary Disease (COPD); GOLD classification III or IV or classified in group B or E of the GOLD ABE assessment tool);
* after cardiac arrest;
* suspected or confirmed pregnancy;
* having 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;
* participation in another interventional trial using similar endpoints;
* previous randomization in this study;
* no informed consent or;
* admitted for palliative and terminal care.

Where it's running

• Reinier De Graaf
  Delft, Nl, Netherlands Recruiting
• Amsterdam UMC, locatie AMC
  Amsterdam, Nl, Netherlands Not yet recruiting

Study contacts

• Principal investigator: Frederique Paulus, Full Professor — Amsterdam AMC, Amsterdam, the Netherlands
• Study coordinator: Laura A. Buiteman-Kruizinga, PhD
• Email: l.a.kruizinga@amsterdamumc.nl
• Phone: +31627153843

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.