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Effects of PERMISSive Lung–protective Ventilation in Critically Ill Invasively Ventilated Patients (PERMISS)

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 - PERMISS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON57603
Enrollment
70
Registered
2025-03-10
Start date
2025-08-31
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

respiratory failure acute breathing failure

Interventions

Permissive lungprotective ventilation with low respiratory rate &nbsp

Sponsors

Reinier de Graaf
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: In order to be eligible to participate in this study, a patient must meet the following 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

Exclusion criteria: Patients who meet any of the following criteria are excluded from participation: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; oradmitted for terminal care

Design outcomes

Primary

MeasureTime frame
The primary endpoint is feasibility, assessed by the difference in respiratory rate (RR) between the two groups, from the start of mechanical ventilation until first extubation. 

Secondary

MeasureTime frame
The secondary endpoints include protocol compliance and feasibility of collecting data. Another secondary endpoint is safety, assessed by the occurrence of unacceptable hypercapnia and hypoxemia and the incidence of ventilator–associated complications.

Countries

Netherlands, Spain

Contacts

Public ContactL.A. Buiteman

Reinier de Graaf

l.kruizinga@rdgg.nl0152604040

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026