FCV vs PCV in Moderate to Severe ARDS

Launched by ERASMUS MEDICAL CENTER · Sep 20, 2023

Keywords

ClinConnect Summary

This clinical trial is exploring two different methods of helping patients with moderate to severe Acute Respiratory Distress Syndrome (ARDS) breathe easier while they are on a ventilator in the intensive care unit. The trial is specifically comparing flow-controlled ventilation (FCV) and pressure-controlled ventilation (PCV) to see which method might be more effective and less intense for the lungs. The researchers want to find out if FCV uses less mechanical power and how it affects lung function compared to PCV.

To participate in this trial, individuals need to be at least 18 years old, have a specific type of breathing problem that meets certain criteria, and be on a ventilator with an endotracheal tube for no more than 72 hours. During the trial, participants will be randomly assigned to receive either 90 minutes of FCV followed by 90 minutes of PCV or the reverse. This means that everyone will have the chance to experience both ventilation methods. It’s important to note that some health conditions, like severe lung issues or unstable blood pressure, may prevent someone from being eligible. If you or a loved one is considering this trial, it could provide valuable information about which ventilation method might be better for managing ARDS.

Gender

ALL

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