Invasive VentilationPERMISSNCT07837128
PERMISSive Lung-protective Ventilation RCT
A study testing Permissive lung-protective ventilation and Conventional lung-protective ventilation in people with Invasive Ventilation and Critical Illness, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Invasive Ventilation, Critical Illness, Intensive Care (ICU)
- What is being tested?
- Permissive lung-protective ventilation and Conventional lung-protective ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 926 participants
- Where
- 2 sitesNetherlands
- Study dates
- Sep 2026to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
Show all 12Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Netherlands2 sites, 2 recruiting
- Not yet recruiting
Amsterdam UMC, locatie AMC
Amsterdam, NL, 1100 DD
Amarens Hoogenboom, MD, +31615147102, h.b.a.hoogenboom@amsterdamumc.nl
Alessandro Caroli, MD, +393297869964, a.caroli@amsterdamumc.nl
- Recruiting
Reinier De Graaf
Delft, NL, 2625 AD
Laura Buiteman-Kruizinga, PhD, +31627153843, l.a.kruizinga@amsterdamumc.nl
About this study
Official title: PERMISSive Lung-protective Ventilation in Critically Ill Invasively Ventilated Patients (PERMISS) - a Randomized Clinical Trial
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:
Read more
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.
Read the detailed description
RATIONALE Injury caused by mechanical ventilation is associated with its intensity, of which the respiratory rate (RR) is a substantial contributor. A permissive ventilation strategy that reduces RR and allows mild hypercapnia, may lower the intensity of ventilation and improve patient-centered outcomes. In this approach, RR is stepwise decreased to the lowest level compatible with predefined safety limits.
OBJECTIVE To compare permissive lung-protective ventilation with a lower RR, to conventional lung-protective ventilation, in adult critically ill patients receiving invasive ventilation.
HYPOTHESIS 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, is 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.
STUDY DESIGN International, multicenter, investigator-initiated, randomized, clinical, superiority trial.
STUDY POPULATION Critically ill patients, aged ≥ 18 years, intubated and expected to receive invasive ventilation for > 24 hours.
INTERVENTION AND COMPARISON Patients are randomized in a 1:1 ratio to permissive lung-protective ventilation with lower RR, or to conventional lung-protective ventilation.
STUDY ENDPOINTS The primary outcome is the number of VFD-28, a composite endpoint of duration of ventilation and death until day 28. The secondary outcomes include the individual components of this composite endpoint, namely duration of ventilation (analyzed separately in survivors and non-survivors) and 28-day mortality. Additional secondary outcomes are intensive care unit (ICU) and hospital length of stay, and ICU-, hospital, and 90-day mortality.
SAMPLE SIZE AND DATA ANALYSIS Based on previous literature, we assumed that the intervention would determine an increase in the number of VFD-28 of 2.4 days, with a standard deviation of 10. The required sample size with a t-test and allowing for a 15% inflation to account for rank-based testing, a power of 90%, an alpha of 0.05 and a drop-out rate of 10% is 926 patients (463 patients per group). Primary analysis will follow the intention-to-treat principle, with additional per-protocol analysis.
NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT AND GROUP RELATEDNESS Ventilation with lower RR may result in higher PaCO2 and lower arterial pH. When kept within safe limits, evidence suggests that hypercapnia and mild acidosis are safe and do not lead to worse outcomes or severe adverse events. Both ventilation strategies are forms of lung-protective ventilation and are currently variably used as part of standard care. No other interventions are performed. Permissive ventilation is most often reserved for patients with severe lung conditions, where ventilator settings are more complex and ventilation intensity is high. In these patients, permissive ventilation is considered safe, and may even be beneficial. The collection of demographics, ventilation and outcome data causes no harm to patients. Blood is drawn for arterial blood gas analysis, but this is also part of standard care.
- Being tested
- Permissive lung-protective ventilation, Conventional lung-protective ventilation
- Keywords
- Intensive Care, Mechanical Ventilation, respiratory rate, mechanical power
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Permissive lung-protective ventilationOther
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 ventilationOther
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 group | Role | What they receive |
|---|---|---|
| Permissive lung-protective ventilation | Experimental | The goal is to achieve the lowest possible respiratory rate (RR) according to a guideline. Receives: Other: Permissive lung-protective ventilation |
| Conventional lung-protective ventilation | Active comparator | The respiratory rate is set according to standard of care. Receives: Other: Conventional lung-protective ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of days free from ventilation and alive at day 28 (VFD-28)
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.
Measured: From start of invasive ventilation to successful liberation from ventilation, death or day 28, whichever occurs first
Secondary outcomes (12)
Duration of ventilation
Time difference between the date and time of the last successful liberation from invasive ventilation episode and the date and time of intubation.
Measured: From start of invasive ventilation to successful liberation from ventilation, death or day 28, whichever occurs first.
28-day mortality
Death for any cause within 28 days
Measured: from randomization to day 28
Intensive Care Unit (ICU) length of stay
Time difference between the date time of ICU discharge and the date and time of randomization
Measured: from randomization to ICU discharge, death or day 90, whichever occurs first.
Hospital length of stay
Time difference between the date time of hospital discharge and the date and time of randomization
Measured: from randomization to hospital discharge, death or day 90, whichever occurs first.
Successful switch to pressure support ventilation
ventilation in pressure support mode at two consecutive time points
Measured: from start of invasive ventilation to successful liberation from ventilation, death or day 28, whichever occurs first.
Intensive Care Unit (ICU) mortality
death from any cause in ICU
Measured: from randomization to day 90
Hospital mortality
death from any cause in hospital
Measured: from randomization to day 90
Incidence of Acute Respiratory Distress Syndrome (ARDS)
ARDS is defined according to the Berlin definition.
Measured: from randomization to day 28
Incidence of Acute Kidney Injury (AKI)
AKI is defined according to the KDIGO guidelines
Measured: from randomization to day 28
Incidence of severe hypercapnia
Severe hypercapnia is defined as PaCO2 > 9.3 kPa (70 mmHg) with severe acidemia defined as pHa < 7.20
Measured: from randomization to end of the intervention
Incidence of severe hypoxemia
Severe hypoxemia is defined as PaO2 < 8 kPa (60 mmHg)
Measured: from randomization to end of the intervention
Incidence of ventilation-associated complications
Ventilator-associated complications are: (1) air leaks, (2) severe atelectasis, (3) ventilator-associated pneumonia, (4) acute cor pulmonale.
Measured: from randomization to end of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study startSep 2026 (estimated)
- Primary completionMar 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Invasive VentilationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- International, multicenter, investigator-initiated, parallel, superiority randomized clinical trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 926 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Laura Buiteman-Kruizinga, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Frederique Paulus, Full Professor, Principal investigator, Amsterdam AMC, Amsterdam, the Netherlands
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837128
- Sponsor's protocol ID
- NL-011976
- Other IDs
- 10390042410066, NL-OMON61463
- Acronym
- PERMISS
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 23 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PERMISSive Lung-protective Ventilation in Critically Ill Invasively Ventilated Patients (PERMISS) - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07837128
- Acronym / sponsor ID
- PERMISS / NL-011976
- Keywords
- Intensive Care, Mechanical Ventilation, respiratory rate, mechanical power
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 926 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Mar 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
RATIONALE Injury caused by mechanical ventilation is associated with its intensity, of which the respiratory rate (RR) is a substantial contributor. A permissive ventilation strategy that reduces RR and allows mild hypercapnia, may lower the intensity of ventilation and improve patient-centered outcomes. In this approach, RR is stepwise decreased to the lowest level compatible with predefined safety limits.
OBJECTIVE To compare permissive lung-protective ventilation with a lower RR, to conventional lung-protective ventilation, in adult critically ill patients receiving invasive ventilation.
HYPOTHESIS 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, is 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.
STUDY DESIGN International, multicenter, investigator-initiated, randomized, clinical, superiority trial.
STUDY POPULATION Critically ill patients, aged ≥ 18 years, intubated and expected to receive invasive ventilation for > 24 hours.
INTERVENTION AND COMPARISON Patients are randomized in a 1:1 ratio to permissive lung-protective ventilation with lower RR, or to conventional lung-protective ventilation.
STUDY ENDPOINTS The primary outcome is the number of VFD-28, a composite endpoint of duration of ventilation and death until day 28. The secondary outcomes include the individual components of this composite endpoint, namely duration of ventilation (analyzed separately in survivors and non-survivors) and 28-day mortality. Additional secondary outcomes are intensive care unit (ICU) and hospital length of stay, and ICU-, hospital, and 90-day mortality.
SAMPLE SIZE AND DATA ANALYSIS Based on previous literature, we assumed that the intervention would determine an increase in the number of VFD-28 of 2.4 days, with a standard deviation of 10. The required sample size with a t-test and allowing for a 15% inflation to account for rank-based testing, a power of 90%, an alpha of 0.05 and a drop-out rate of 10% is 926 patients (463 patients per group). Primary analysis will follow the intention-to-treat principle, with additional per-protocol analysis.
NATURE AND EXTENT OF THE BURDEN AND RISKS ASSOCIATED WITH PARTICIPATION, BENEFIT AND GROUP RELATEDNESS Ventilation with lower RR may result in higher PaCO2 and lower arterial pH. When kept within safe limits, evidence suggests that hypercapnia and mild acidosis are safe and do not lead to worse outcomes or severe adverse events. Both ventilation strategies are forms of lung-protective ventilation and are currently variably used as part of standard care. No other interventions are performed. Permissive ventilation is most often reserved for patients with severe lung conditions, where ventilator settings are more complex and ventilation intensity is high. In these patients, permissive ventilation is considered safe, and may even be beneficial. The collection of demographics, ventilation and outcome data causes no harm to patients. Blood is drawn for arterial blood gas analysis, but this is also part of standard care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- International, multicenter, investigator-initiated, parallel, superiority randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| Permissive lung-protective ventilation | Experimental | Other: Permissive lung-protective ventilationThe goal is to achieve the lowest possible respiratory rate (RR) according to a guideline. |
| Conventional lung-protective ventilation | Active comparator | Other: Conventional lung-protective ventilationThe respiratory rate is set according to standard of care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (12 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Permissive lung-protective ventilationThe 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. | Other | Permissive lung-protective ventilation |
| Conventional lung-protective ventilationThe 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. | Other | Conventional lung-protective ventilation |
Primary outcome
Number of days free from ventilation and alive at day 28 (VFD-28)
Time frame: 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.
12 secondary outcomes
Duration of ventilation
Time frame: From start of invasive ventilation to successful liberation from ventilation, death or day 28, whichever occurs first.
28-day mortality
Time frame: from randomization to day 28
Intensive Care Unit (ICU) length of stay
Time frame: from randomization to ICU discharge, death or day 90, whichever occurs first.
Hospital length of stay
Time frame: from randomization to hospital discharge, death or day 90, whichever occurs first.
Successful switch to pressure support ventilation
Time frame: from start of invasive ventilation to successful liberation from ventilation, death or day 28, whichever occurs first.
Intensive Care Unit (ICU) mortality
Time frame: from randomization to day 90
Hospital mortality
Time frame: from randomization to day 90
Incidence of Acute Respiratory Distress Syndrome (ARDS)
Time frame: from randomization to day 28
Incidence of Acute Kidney Injury (AKI)
Time frame: from randomization to day 28
Incidence of severe hypercapnia
Time frame: from randomization to end of the intervention
Incidence of severe hypoxemia
Time frame: from randomization to end of the intervention
Incidence of ventilation-associated complications
Time frame: from randomization to end of the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Frederique Paulus, Full Professor principal investigator
Amsterdam AMC, Amsterdam, the Netherlands
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Permissive lung-protective ventilation and Conventional lung-protective ventilation in people with Invasive Ventilation and Critical Illness, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 2 sites in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Laura A. Buiteman-Kruizinga, PhD (+31627153843, l.a.kruizinga@amsterdamumc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of days free from ventilation and alive at day 28 (VFD-28) (time frame: From start of invasive ventilation to successful liberation from ventilation, death or day 28, whichever occurs first). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2026.