Actively Recruiting
FCV Vs VCV in Obstructive and Asthmatic Patients
Led by Erasmus Medical Center · Updated on 2024-10-18
10
Participants Needed
2
Research Sites
156 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 physiological pilot study with a randomized crossover design is to study the effect of Flow-controlled ventilation (FCV) on the minute volume compared to Volume-controlled ventilation (VCV) in intubated patients with an exacerbation of their asthma or COPD. Our hypothesis is that FCV will results in a lower minute volume compared to VCV in this patient category. Patients will be randomized between two ventilation sequences, namely 90 minutes of FCV followed by 90 minutes of VCV or vice versa.
CONDITIONS
Official Title
FCV Vs VCV in Obstructive and Asthmatic Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 18 years or older
- Provided written informed consent
- Undergoing controlled mechanical ventilation via an endotracheal tube
- Reason for intubation being exacerbation of asthma or COPD
- Intubated 672 hours
You will not qualify if you...
- 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
- 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
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
Actively Recruiting
2
Maasstad Hospital
Rotterdam, South Holland, Netherlands, 3079DZ
Actively Recruiting
Research Team
J
Julien P Van Oosten, MD
CONTACT
A
Annemijn H Jonkman, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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