FCV vs PCV in Moderate to Severe ARDS

NCT06051188 | Recruiting

• 1 other identifier: ABR NL83234.078.23
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Acute Respiratory Distress Syndrome; Ventilator Lung

Keywords

Flow-controlled ventilation; ARDS; Electrical Impedance Tomography; Mechanical Power

Outcome Measures

Primary Outcomes (1)

• Mechanical power

  Difference in mechanical power in J/min after 90 minutes of flow-controlled ventilation and 90 minutes of pressure-controlled ventilation

  90 minutes

Secondary Outcomes (10)

• End-expiratory lung volume

  30 minutes

• Dissipated energy

  90 minutes

• Airway pressures

  30 and 90 minutes

• Transpulmonary pressures

  30 and 90 minutes

• Minute volume

  30 and 90 minutes

Study Arms (2)

FCV-PCV

EXPERIMENTAL

90 minutes of flow-controlled ventilation followed by 90 minutes of pressure-controlled ventilation.

Device: Flow-controlled ventilation

PCV-FCV

EXPERIMENTAL

90 minutes of pressure-controlled ventilation followed by 90 minutes of flow-controlled ventilation.

Device: Flow-controlled ventilation

Interventions

Flow-controlled ventilation DEVICE

Flow-controlled ventilation (FCV)

FCV-PCV; PCV-FCV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Maasstad Hospital: collaborator

Study Sites (1)

Maasstad Hospital

Rotterdam, South Holland, 3079DZ, Netherlands

RECRUITING

Related Publications (1)

• van Oosten JP, Francovich JE, Weller D, Rietdijk W, Goedendorp N, Somhorst P, den Uil CA, Gommers D, Jonkman AH, Endeman H. Flow-controlled ventilation versus pressure-controlled ventilation in moderate to severe ARDS patients: a randomized crossover physiological study. Intensive Care Med Exp. 2025 Dec 24;13(1):137. doi: 10.1186/s40635-025-00847-4.

  PMID: 41442110 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders

Study Officials

• Rik Endeman, Dr

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julien van Oosten, MD

CONTACT

+31630600232; j.vanoosten@erasmusmc.nl

Annemijn Jonkman, Dr

CONTACT

+31627858466; a.jonkman@erasmusmc.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized crossover physiological pilot study

Study Record Dates

• First Submitted: September 7, 2023
• First Posted: September 22, 2023
• Study Start: September 12, 2023
• Primary Completion: May 1, 2025
• Study Completion: May 1, 2026
• Last Updated: December 1, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)