Permissive lung-protective ventilation for adults on invasive ventilators

Effects of PERMISSive Lung-protective Ventilation on Outcome in Critically Ill Invasively Ventilated Patients (PERMISS) - a Feasibility and Safety Pilot Study for a Randomized Clinical Trial

This tests whether using a lower breathing rate on the ventilator (allowing higher CO2) is safe and workable for adults in the ICU who are invasively ventilated for acute low oxygen levels.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 84 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Reinier de Graaf Groep (Academic / other)
• Locations: 5 sites (Almelo and 4 other locations)
• Trial ID: NCT07077174 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults (over 18) admitted to participating ICUs who are intubated for acute hypoxemic respiratory failure and expected to need invasive ventilation for more than 24 hours, without ECMO, severe COPD, or contraindications to permissive hypercapnia, are ideal candidates.

Not a fit: Patients with contraindications to hypercapnia (recent cardiac ischemia or raised intracranial pressure), those on ECMO, or with severe COPD (GOLD III/IV) are unlikely to benefit from this strategy.

Why it matters

Potential benefit: If successful, this approach could lower the intensity of ventilator support and reduce ventilator-related lung injury and complications.

How similar studies have performed: Related lung-protective approaches such as low tidal volume ventilation with permissive hypercapnia have shown benefit in ARDS, but specifically lowering respiratory rate to reduce mechanical power is less tested and remains novel in large trials.

Eligibility criteria

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 this trial is running

Almelo and 4 other locations

• ZiekenhuisGroep Twente — Almelo, Netherlands (Recruiting)
• Amsterdam UMC — Amsterdam, Netherlands (Not_yet_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

Conditions Mechanical Ventilation; Intensive Care; mechanical ventilation; intensive care unit; mechanical power; respiratory rate