FCV vs VCV in Obstructive and Asthmatic Patients
Recruiting · NCT06563544 · Interventional (participants receive a specific treatment) · Lead sponsor: Erasmus Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
FCV
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.
Who can take part
Age range
18 Years to 100 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 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
- 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
Where it is running
4 locations listed.
- Erasmus Medical Center - Rotterdam, South Holland, Netherlands
- Maasstad Hospital - Rotterdam, South Holland, Netherlands
- Erasmus Medical Center - Rotterdam, South Holland, Netherlands
- Maasstad Hospital - Rotterdam, South Holland, Netherlands