Comparing two ventilation methods for patients with severe lung issues

Flow Versus Pressure Controlled Ventilation in Patients With Moderate to Severe Acute Respiratory Distress Syndrome

This study is testing whether a new way of helping people with severe lung problems breathe can work better than the usual method in the intensive care unit.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 28 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Erasmus Medical Center (other)
• Drugs / interventions: radiation
• Locations: 1 site (Rotterdam, South Holland)
• Trial ID: NCT06051188 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare flow-controlled ventilation (FCV) and pressure-controlled ventilation (PCV) in patients suffering from moderate to severe acute respiratory distress syndrome (ARDS) in an intensive care setting. Participants will be randomly assigned to receive either FCV or PCV for 90 minutes each, allowing researchers to assess differences in mechanical power and other physiological effects between the two methods. The study seeks to understand how FCV may reduce alveolar collapse and improve ventilation efficiency compared to traditional PCV.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who are intubated and undergoing controlled mechanical ventilation due to moderate to severe ARDS.

Not a fit: Patients with severe sputum production requiring frequent suctioning or untreated pneumothorax may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved ventilation strategies that minimize lung injury in patients with ARDS.

How similar studies have performed: Previous studies have shown promising results for flow-controlled ventilation in animal models and smaller human studies, suggesting potential benefits over traditional methods.

Eligibility criteria

Inclusion Criteria:

* 18 years or older
* Provided written informed consent
* Undergoing controlled mechanical ventilation via an endotracheal tube
* Meeting all criteria of the Berlin definition of ARDS

  * Hypoxic respiratory failure within 1 week of a known clinical insult or new or worsening respiratory symptoms
  * Bilateral opacities on X-ray or CT-scan not fully explained by effusions, lobar/lung collapse (atelectasis), or nodules
  * Respiratory failure not fully explained by cardiac failure or fluid overload.
  * Oxygenation: moderate ARDS P/F ratio between 101-200 mmHg, severe ARDS PF ratio ≤ 100mmHg, both with PEEP ≥ 5 cmH2O.
* 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
* Intubated \> 72 hours
* 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

• Maasstad Hospital — Rotterdam, South Holland, Netherlands (RECRUITING)

Study contacts

• Principal investigator: Rik Endeman, Dr — Erasmus Medical Center
• Study coordinator: Julien van Oosten, MD

Conditions: Acute Respiratory Distress Syndrome, Ventilator Lung, Flow-controlled ventilation, ARDS, Electrical Impedance Tomography, Mechanical Power