Comparing two ventilation methods in patients with asthma and COPD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the effects of Flow-controlled ventilation (FCV) versus Volume-controlled ventilation (VCV) on minute volume in intubated patients experiencing exacerbations of asthma or chronic obstructive pulmonary disease (COPD). Patients will be randomly assigned to receive each ventilation method for 90 minutes in a crossover design. The study seeks to determine if FCV can reduce minute volume compared to VCV, potentially leading to fewer complications associated with mechanical ventilation. The rationale is based on the understanding that dynamic hyperinflation during mechanical ventilation can lead to serious complications in these patients.

Why it matters

Who can join: the full rules

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's running

• Erasmus Medical Center
  Rotterdam, South Holland, Netherlands Recruiting
• Maasstad Hospital
  Rotterdam, South Holland, Netherlands Recruiting

Study contacts

• Study coordinator: Julien P Van Oosten, MD
• Email: j.vanoosten@erasmusmc.nl
• Phone: +31630600232

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.