New ventilation technique tested in ICU patients with severe lung failure
NCT ID NCT06051188
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This trial tested a new way of using a breathing machine (flow-controlled ventilation) against the standard method (pressure-controlled ventilation) in 15 ICU patients with moderate to severe acute respiratory distress syndrome (ARDS). The goal was to see if the new method uses less energy on the lungs and improves lung function. The study was stopped early, so results are limited.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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15 people
The number who actually took part.
- Started
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Sep 2023
- Finished
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Nov 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 of EIT-belt * Recent (\<7 days) pulmonary surgery including pneumonectomy, lobectomy or lung transplantation * ICD device present (potential interference with proper functioning of the EIT device and ICD device) * Excessive subcutaneous emphysema * Contra-indications for nasogastric tube or inability to perform adequate transpulmonary pressure measurements with, e.g.: * Recent esophageal surgery * Prior esophagectomy * Known presence of esophageal varices * Severe bleeding disorders
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Erasmus Medical Center
Rotterdam, 3015 GD, Netherlands
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Maasstad Hospital
Rotterdam, South Holland, 3079DZ, Netherlands
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Other studies related to the condition(s) this trial covers.
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