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RECRUITING

NCT06051188

FCV vs PCV in Moderate to Severe ARDS

Sponsor: Erasmus Medical Center

View on ClinicalTrials.gov

Summary

The goal of this clinical trial is to compare flow-controlled ventilation (FCV) and pressure-controlled ventilation (PCV) in patients with moderate to severe acute respiratory distress syndrome on the intensive care unit. The main questions it aims to answer are: * Is the mechanical power during flow-controlled ventilation lower than during pressure-controlled ventilation * To gain more understanding about other physiological effects and potential benefits of flow-controlled ventilation in comparison to pressure-controlled ventilation (o.a. the end-expiratory lung volume and homogeneity of ventilation). Participants will be randomized between two ventilation mode sequences, being 90 minutes of FCV followed by 90 minutes of PCV or vice versa.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

Start Date

2023-09-12

Completion Date

2026-05

Last Updated

2023-12-01

Healthy Volunteers

Conditions

Acute Respiratory Distress Syndrome Ventilator Lung

Interventions

DEVICE

Flow-controlled ventilation

Flow-controlled ventilation (FCV)

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

Locations (1)

Maasstad Hospital

Rotterdam, South Holland, Netherlands