Status:
RECRUITING
FCV Vs VCV in Obstructive and Asthmatic Patients
Lead Sponsor:
Erasmus Medical Center
Collaborating Sponsors:
Maasstad Hospital
Conditions:
Obstructive Pulmonary Disease
Mechanical Ventilation Pressure High
Eligibility:
All Genders
18-100 years
Phase:
NA
Brief Summary
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...
Detailed Description
Rationale: Patients with an exacerbation of asthma or chronic obstructive pulmonary disease (COPD) requiring controlled mechanical ventilation (CMV) on the intensive care unit (ICU) have a mortality r...
Eligibility Criteria
Inclusion
- 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 ≤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
- 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 :
October 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2027
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06563544
Start Date
October 1 2024
End Date
October 1 2027
Last Update
October 18 2024
Active Locations (2)
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1
Erasmus Medical Center
Rotterdam, South Holland, Netherlands, 3015 GD
2
Maasstad Hospital
Rotterdam, South Holland, Netherlands, 3079DZ