FCV vs PCV in Moderate to Severe ARDS
Flow Versus Pressure Controlled Ventilation in Patients With Moderate to Severe Acute Respiratory Distress Syndrome
Erasmus Medical Center
28 participants
Sep 12, 2023
INTERVENTIONAL
Conditions
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
Inclusion Criteria9
- 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 Criteria18
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Flow-controlled ventilation (FCV)
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06051188