Comparing two ventilation methods in patients with asthma and COPD

Flow Versus Volume-Controlled Ventilation in Intubated Obstructive and Asthmatic Patients

This study is testing whether a new way of helping people with asthma or COPD breathe on a ventilator can reduce breathing problems compared to a standard method.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 100 Years
• Sex: All
• Sponsor: Erasmus Medical Center (Academic / other)
• Drugs / interventions: radiation
• Locations: 2 sites (Rotterdam, South Holland and 1 other locations)
• Trial ID: NCT06563544 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older who are intubated due to exacerbations of asthma or COPD and have been on mechanical ventilation for 72 hours or less.

Not a fit: Patients with severe sputum production, untreated pneumothorax, or those anticipating withdrawal of life support may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved ventilation strategies that reduce complications and mortality in patients with asthma and COPD exacerbations.

How similar studies have performed: While this approach is novel in this specific context, similar studies exploring different ventilation strategies have shown promising results in improving patient outcomes.

Eligibility criteria

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 this trial is running

Rotterdam, South Holland and 1 other locations

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

Study contacts

• Study coordinator: Julien P Van Oosten, MD

Conditions Obstructive Pulmonary Disease; Mechanical Ventilation Pressure High; Asthma COPD