Status:
RECRUITING
FCV vs PCV in Moderate to Severe ARDS
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Maasstad Hospital
Conditions:
Acute Respiratory Distress Syndrome
Ventilator Lung
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
Rationale: During controlled mechanical ventilation (CMV) only the inspiration is controlled by either a set driving pressure (Pressure Controlled Ventilation, PCV) or tidal volume (Volume Controlled ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT06051188
Start Date
September 12 2023
End Date
May 1 2026
Last Update
December 1 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Maasstad Hospital
Rotterdam, South Holland, Netherlands, 3079DZ