| NCT ID | NCT06051188 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Acute Respiratory Distress Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 28 participants |
| Start Date | 2023-09-12 |
| Primary Completion | 2025-05 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 28 participants in total. It began in 2023-09-12 with a primary completion date of 2025-05.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Rik Endeman, Dr
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT06051188 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Respiratory Distress Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06051188 currently recruiting?
Yes, NCT06051188 is actively recruiting participants. Contact the research team at j.vanoosten@erasmusmc.nl for enrollment information.
Where is the NCT06051188 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT06051188 clinical trial?
NCT06051188 is sponsored by Erasmus Medical Center. The principal investigator is Rik Endeman, Dr at Erasmus Medical Center. The trial plans to enroll 28 participants.