Actively Recruiting
FCV vs PCV in Moderate to Severe ARDS
Led by Erasmus Medical Center · Updated on 2023-12-01
28
Participants Needed
1
Research Sites
137 weeks
Total Duration
On this page
Sponsors
E
Erasmus Medical Center
Lead Sponsor
M
Maasstad Hospital
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
FCV vs PCV in Moderate to Severe ARDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
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18 years or older
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Provided written informed consent
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Undergoing controlled mechanical ventilation via an endotracheal tube
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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.
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Intubated ≤72 hours
You will not qualify if you...
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Severe sputum stasis or production requiring frequent bronchial suctioning (more than 5 times per nurse shift)
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Untreated pneumothorax (i.e., no pleural drainage)
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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
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High (>15 mmHg) or instable (an increase in sedation or osmotherapy is required) intracranial pressure
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An inner tube diameter of 6mm or less
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Intubated > 72 hours
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Anticipating withdrawal of life support and/or shift to palliation as the goal of care
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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
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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
AI-Screening
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Trial Site Locations
Total: 1 location
1
Maasstad Hospital
Rotterdam, South Holland, Netherlands, 3079DZ
Actively Recruiting
Research Team
J
Julien van Oosten, MD
CONTACT
A
Annemijn Jonkman, Dr
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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