Permissive lung-protective ventilation for adults on invasive ventilators

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

This is a multicenter, randomized pilot trial comparing a permissive lung-protective ventilation strategy (lower respiratory rate with permissive hypercapnia) to conventional lung-protective ventilation in adult ICU patients intubated for acute hypoxemic respiratory failure. The primary goals are to determine feasibility and safety and to inform the design of a larger randomized trial focused on patient-centered outcomes. Key exclusions include prior prolonged ventilation before ICU admission, use of ECMO, severe COPD (GOLD III/IV), and contraindications to hypercapnia such as ongoing cardiac ischemia or raised intracranial pressure. Enrolment occurs at participating Dutch hospitals and patients are randomized to one of the two ventilation approaches while closely monitored for respiratory and systemic effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* admission to one of the participating ICUs;
* intubated and receiving invasive ventilation with an expected duration of ventilation of at least 24 hours.

Exclusion Criteria:

* age below 18 years;
* receiving invasive ventilation \> 1 hour in the ICU, or receiving invasive ventilation \> 6 hours directly preceding the current ICU admission (i.e., in the operating room or in the emergency department);
* 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;
* 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

Where it's running

• ZiekenhuisGroep Twente
  Almelo, Netherlands Recruiting
• Amsterdam UMC
  Amsterdam, Netherlands Recruiting
• Reinier de Graaf Hospital
  Delft, Netherlands Recruiting
• Dijklander Hospital
  Hoorn, Netherlands Recruiting
• Vall d'Hebron
  Barcelona, Spain Recruiting

Study contacts

• Principal investigator: Laura Buiteman-Kruizinga, RN, PhD — Reinier de Graaf Groep
• Study coordinator: Laura A. Buiteman-Kruizinga, RN, PhD
• Email: l.kruizinga@rdgg.nl
• Phone: +31152604040

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Inspiratory Effort and Dyspnea During Assisted Mechanical Ventilation in Critically Ill Adults

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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.