PERMISSive Lung-protective Ventilation RCT
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
About this 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:
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 criteria
This trial does not accept healthy volunteersQualifiers
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).
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Permissive lung-protective ventilation
Other interventionThe 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
Other interventionThe 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.
Treatment groups
926 Participants
are divided into 2 treatment groupsGroup A: Permissive lung-protective ventilationExperimental treatment 1 intervention
Group B: Conventional lung-protective ventilationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
From start of invasive ventilation to successful liberation from ventilation, death or day 28, whichever occurs firstSecondary outcomes
1
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.
Time frame
From start of invasive ventilation to successful liberation from ventilation, death or day 28, whichever occurs first.2
28-day mortality
Death for any cause within 28 days
Time frame
from randomization to day 283
Intensive Care Unit (ICU) length of stay
Time difference between the date time of ICU discharge and the date and time of randomization
Time frame
from randomization to ICU discharge, death or day 90, whichever occurs first.4
Hospital length of stay
Time difference between the date time of hospital discharge and the date and time of randomization
Time frame
from randomization to hospital discharge, death or day 90, whichever occurs first.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov