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Recruiting Not applicable

Dead Space in Mechanical Ventilation With Constant Expiratory Flow

NCT06024993 · tracked via the Priya Life Science Belgium tracker
Phase
Not applicable
Started
2024-07-22
Last updated
2025-01-22

Condition(s) studied

Mechanical VentilationArtificial Respiration

Investigational drug(s) / intervention(s)

Flow-controlled ventilation (FCV)Conventional volume-controlled ventilation (VCV)

Flow-controlled ventilation (FCV): 20 minutes of FCV, delivered with the CE-marked Evone ventilator (Ventinova medical, the Netherlands)

Conventional volume-controlled ventilation (VCV): 20 minutes of conventional VCV, delivered with the CE-marked Aisys CS3 (GE Healthcare, USA) or Flow-i (Getinge, Sweden) ventilators.

Study summary

Conventional continuous mandatory mechanical ventilation relies on the passive recoil of the chest wall for expiration. This results in an exponentially decreasing expiratory flow.

Flow controlled ventilation (FCV), a new ventilation mode with constant, continuous, controlled expiratory flow, has recently become clinically available and is increasingly being adopted for complex mechanical ventilation during surgery.

In both clinical and pre-clinical settings, an improvement in ventilation (CO2 clearance) has been observed during FCV compared to conventional ventilation. Recently, Schranc et al. compared flow-controlled ventilation with pressure-regulated volume control in both double lung ventilation and one-lung ventilation in pigs. They report differences in dead space ventilation that may explain the improved CO2 clearance, although their study was not designed to compare dead space ventilation within the group of double lung ventilation.

Dead space ventilation, or "wasted ventilation", is the ventilation of hypoperfused lung zones, and is clinically relevant, as it is a strong predictor of mortality in patients with the acute respiratory distress syndrome (ARDS) and is correlated with higher airway driving pressures which are thought to be injurious to the lung (lung stress).

This trial aims to study the difference in dead space ventilation between conventional mechanical ventilation in volume-controlled mode and flow controlled-ventilation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Adults \[18-70\] yrs * General anaesthesia for elective surgery * Arterial line, central venous line and endotracheal tube as part of standard of care * Expected duration of controlled mechanical ventilation ≥ 60 minutes * Supine position (0±10°) Exclusion Criteria: * One lung ventilation * Known pregnancy * Increased intra-abdominal pressure (pneumoperitoneum or obesity (BMI \> 30kg/m2)) * COPD GOLD IV or home oxygen dependence * Cardiac pacemaker, implantable cardioverter-defibrillator (ICD) or thoracic neurostimulator * Skin lesions (e.g. injury, inflammation) at the level where the Electrical Impedance Tomography (EIT) band is to be applied * Clinical signs of raised intracranial pressure * Potential interference with the surgery due to the setup of the study instruments. * Patient refusal to participate

Primary outcome measure(s)

  • Change in Bohr dead space ventilation (VDBr/VT) — During FCV and VCV measurements (20 minutes)
    Quantified by the Bohr approach with volumetric capnography

Trial sites (1)

FacilityCityRegionStatus
Antwerp University Hospital (UZA) Edegem Antwerp Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06024993 on ClinicalTrials.gov ↗ ← All trials in Belgium