PERMISSive Lung-protective Ventilation RCT

NCT07837128 · tracked via the Priya Life Science Netherlands tracker

Sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Phase

Not applicable

Started

2026-09

Last updated

2026-09-23

Condition(s) studied

Invasive VentilationCritical IllnessIntensive Care (ICU)Mechanical Ventilation

Investigational drug(s) / intervention(s)

Permissive lung-protective ventilationConventional lung-protective ventilation

Permissive lung-protective ventilation: The goal is to achieve the lowest possible respiratory rate (RR) guided by a nomogram, that integrates baseline RR with arterial blood gas analysis (ABG) results, to stay within safety limits of PaCO2 and pH. The lowest RR possible is determined by the maximum acceptable PaCO2 of ≤ 8.5 kPa (64 mmHg) and limited by the lowest acceptable pH of \> 7.20, depending on the combination. The nomogram provides guidance on RR reductions based on these safety limits. The first target RR is determined using the baseline RR and the first ABG, obtained within 1 hour after randomization. The set RR is gradually decreased in steps of 2 breaths, approximately every 10 to 20 minutes, and downtitration is intended to be completed between 4 to 6 hours. Other ventilator settings are set according to lung-protective ventilation, following international guidelines.

Conventional lung-protective ventilation: The respiratory rate (RR) is set according to standard of care, starting to target a normal PaCO2 (4.7-6.4 kPa or 35-48 mmHg) and/or a normal arterial pH (7.35-7.45). Other ventilator settings according to lung-protective ventilation, following international guidelines.

Study summary

The goal of this clinical trial is to investigate the impact of a ventilation strategy with a lower respiratory rate (RR) (permissive lung-protective ventilation) on clinical outcomes in adult critically ill patients receiving invasive ventilation.

The main question it aims to answer is:

Is a permissive lung-protective ventilation, defined as a strategy that reduces ventilatory intensity by stepwise lowering RR to the lowest level permitted by predefined safety limits, superior to conventional lung-protective ventilation, with respect to the number of days free from ventilation and alive at day 28 (VFD-28) in adult critically ill patients receiving invasive ventilation?

Researchers will compare permissive lung-protective ventilation with conventional lung-protective ventilation to see if it improves clinical outcomes.

Participants will be randomly assigned to one of the two ventilation strategies under investigation and followed up for 28 days.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Number of days free from ventilation and alive at day 28 (VFD-28) — From start of invasive ventilation to successful liberation from ventilation, death or day 28, whichever occurs first
Ventilator-free days at day 28 (VFD-28) is defined as: * VFD-28 = 0 if a subject dies within 28 days of start of invasive ventilation; * VFD-28 = 0 if a subject is invasively ventilated for ≥28 days; * VFD-28 = 28 - X days after tracheal intubation if a subject is successfully liberated from ventilation.

Trial sites (2)

Facility	City	Region	Status
Amsterdam UMC, locatie AMC	Amsterdam	NL	Not Yet Recruiting
Reinier De Graaf	Delft	NL	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07837128 on ClinicalTrials.gov ↗ ← All trials in the Netherlands