Actively Recruiting
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
Led by Reinier de Graaf Groep · Updated on 2026-02-19
84
Participants Needed
5
Research Sites
4 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating a ventilation strategy called permissive lung-protective ventilation for adult patients who are critically ill and require invasive ventilation due to acute hypoxemic respiratory failure. This pilot study aims to test the feasibility and safety of using a lower respiratory rate during mechanical ventilation, which may involve allowing mild increases in carbon dioxide levels (permissive hypercapnia). The goal is to gather information to guide a larger future clinical trial focused on patient-centered outcomes. Participants are randomly assigned to one of two groups. The experimental group receives permissive lung-protective ventilation, where the respiratory rate is gradually reduced based on blood gas analysis and continuous monitoring, targeting certain limits for carbon dioxide levels and blood acidity. The control group receives conventional lung-protective ventilation following standard care, aiming to maintain normal carbon dioxide and blood pH levels. Both strategies continue until patients begin spontaneous breathing, with careful monitoring through repeated blood gas tests. During the study, patient data including ventilation settings, blood gases, and clinical outcomes are collected. Researchers assess the primary outcome of feasibility by comparing respiratory rates between groups from the start of ventilation until the first extubation, up to 28 days. They also monitor safety outcomes such as unacceptable levels of carbon dioxide and oxygen, protocol adherence, and ventilator-associated complications. Follow-up assessments continue up to 90 days to evaluate data collection feasibility and patient status. Overall participation can last up to three months.
CONDITIONS
Brief Title
Effects of PERMISSive Lung-protective Ventilation on Outcome in Critically Ill Invasively Ventilated Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admission to one of the participating intensive care units (ICUs)
- Intubated and receiving invasive ventilation expected to last at least 24 hours
- Age 18 years or older
You will not qualify if you...
- Age below 18 years
- Receiving invasive ventilation for more than 1 hour in the ICU or more than 6 hours before ICU admission
- Receiving or planned to receive extracorporeal membrane oxygenation (ECMO)
- Diagnosis of severe COPD classified as GOLD III or IV
- Contraindication for hypercapnia such as ongoing cardiac ischemia or suspected/confirmed increased intracranial pressure
- Neurologic diagnoses that may prolong ventilation, such as Guillain-Barré syndrome, high spinal cord lesion, amyotrophic lateral sclerosis, multiple sclerosis, or myasthenia gravis
- Suspected or confirmed pregnancy
- Participation in another interventional trial with similar endpoints
- Previously randomized in this study
- No informed consent
- Admitted for terminal care
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Participants are assessed for eligibility within the first hour after start of ventilation in the ICU.
Duration - From the start of mechanical ventilation until first extubation, up to 28 days
Participants receive either permissive lung-protective ventilation or conventional lung-protective ventilation while invasively ventilated in the ICU.
Blood gas analyses are performed every hour for at least 6 hours, then at least every 8 hours during nursing shifts until weaning or switch to spontaneous breathing.
Trial Site Locations
Total: 5 locations
1
ZiekenhuisGroep Twente
Almelo, Netherlands
Actively Recruiting
2
Amsterdam UMC
Amsterdam, Netherlands
Not Yet Recruiting
3
Reinier de Graaf Hospital
Delft, Netherlands
Actively Recruiting
4
Dijklander Hospital
Hoorn, Netherlands
Actively Recruiting
5
Vall d'Hebron
Barcelona, Spain
Actively Recruiting
Research Team
L
Laura A. Buiteman-Kruizinga, RN, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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