FCV vs PCV in Moderate to Severe ARDS (NCT06051188) | Clinical Trial Compass
TerminatedNot Applicable
FCV vs PCV in Moderate to Severe ARDS
Stopped: Not able to apply FCV as intended by manufacturer
Netherlands15 participantsStarted 2023-09-12
Plain-language summary
The goal of this clinical trial is to compare flow-controlled ventilation (FCV) and pressure-controlled ventilation (PCV) in patients with moderate to severe acute respiratory distress syndrome on the intensive care unit.
The main questions it aims to answer are:
* Is the mechanical power during flow-controlled ventilation lower than during pressure-controlled ventilation
* To gain more understanding about other physiological effects and potential benefits of flow-controlled ventilation in comparison to pressure-controlled ventilation (o.a. the end-expiratory lung volume and homogeneity of ventilation).
Participants will be randomized between two ventilation mode sequences, being 90 minutes of FCV followed by 90 minutes of PCV or vice versa.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 18 years or older
* Provided written informed consent
* Undergoing controlled mechanical ventilation via an endotracheal tube
* Meeting all criteria of the Berlin definition of ARDS
* Hypoxic respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms
* Bilateral opacities on X-ray or CT-scan not fully explained by effusions, lobar/lung collapse (atelectasis), or nodules
* Respiratory failure not fully explained by cardiac failure or fluid overload.
* Oxygenation: moderate ARDS P/F ratio between 101-200 mmHg, severe ARDS PF ratio ≤ 100mmHg, both with PEEP ≥ 5 cmH2O.
* Intubated ≤72 hours
Exclusion Criteria:
* Severe sputum stasis or production requiring frequent bronchial suctioning (more than 5 times per nurse shift)
* Untreated pneumothorax (i.e., no pleural drainage)
* Hemodynamic instability defined as a mean arterial pressure below 60mmHg not responding to fluids and/or vasopressors or a noradrenalin dose \>0.5mcrg/kg/min
* High (\>15 mmHg) or instable (an increase in sedation or osmotherapy is required) intracranial pressure
* An inner tube diameter of 6mm or less
* Intubated \> 72 hours
* Anticipating withdrawal of life support and/or shift to palliation as the goal of care
* Inability to perform adequate electrical impedance tomography (EIT) measurements with, e.g.:
* Have a thorax circumference inappropriate for EIT-belt
* Thoracic wounds, bandages or deformities preventing adequate fit …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.