Actively Recruiting
Flow Versus Volume-Controlled Ventilation in Intubated Obstructive and Asthmatic Patients
Led by Erasmus Medical Center · Updated on 2024-10-18
10
Participants Needed
2
Research Sites
52 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
Researchers are evaluating the effects of Flow-controlled ventilation (FCV) compared to Volume-controlled ventilation (VCV) in patients aged 18 years and older who are intubated due to an exacerbation of asthma or chronic obstructive pulmonary disease (COPD). This pilot study uses a randomized crossover design to test whether FCV can reduce the minute volume and dynamic hyperinflation in these patients, which may help decrease common complications associated with mechanical ventilation such as pneumothorax and cardiovascular collapse. Participants are mechanically ventilated using either FCV or VCV for two separate 90-minute periods, with patients randomized to begin with one mode before switching to the other. FCV delivers a low and constant flow during both inspiration and expiration, aiming to reduce airway resistance and prevent airway collapse, while VCV is set according to standard care. Measurements include flow, pressures, lung volumes, and gas exchange monitored by devices such as an electrical impedance tomography belt and an esophageal balloon. During the 180-minute study, patients receive continuous monitoring of ventilation parameters and hemodynamic status, with adjustments made to optimize compliance and carbon dioxide levels during FCV. Researchers assess the primary outcome of minute volume after 90 minutes on each ventilation mode and secondary outcomes including end-inspiratory lung volume and airway pressures. Because all patients are sedated and on mechanical ventilation, no additional discomfort is expected. The study includes safety monitoring to promptly manage any adverse events.
CONDITIONS
Brief 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 72 hours or less
You will not qualify if you...
- Severe sputum stasis or production requiring frequent bronchial suctioning (more than 5 times per nurse shift)
- Untreated pneumothorax (no pleural drainage)
- Hemodynamic instability with mean arterial pressure below 60mmHg not responding to fluids or vasopressors or noradrenalin dose >0.5mcg/kg/min
- High (>15 mmHg) or unstable intracranial pressure requiring sedation or osmotherapy
- Inner tube diameter of 6mm or less
- Anticipated withdrawal of life support or shift to palliative care
- Inability to perform adequate electrical impedance tomography due to thorax size, wounds, bandages, deformities, recent lung surgery, ICD device, or subcutaneous emphysema
- Contraindications for nasogastric tube or transpulmonary pressure measurements including recent esophageal surgery, prior esophagectomy, esophageal varices, or severe bleeding disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 3 hours
Participants receive two different ventilation modes, flow controlled ventilation (FCV) and volume controlled ventilation (VCV), each for 90 minutes in a randomized sequence. Measurements of lung volume and pressures are taken during these periods to compare ventilation effects.
1 continuous treatment period with monitoring
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
A
Annemijn H Jonkman, Dr.
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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