NCT06024993 Dead Space in Mechanical Ventilation With Constant Expiratory Flow
| NCT ID | NCT06024993 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University Hospital, Antwerp |
| Condition | Mechanical Ventilation |
| Study Type | INTERVENTIONAL |
| Enrollment | 13 participants |
| Start Date | 2024-07-22 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 13 participants in total. It began in 2024-07-22 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Vera Saldien, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Antwerp University Hospital / University of Antwerp
Frequently Asked Questions
Who can join the NCT06024993 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Mechanical Ventilation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06024993 currently recruiting?
Yes, NCT06024993 is actively recruiting participants. Contact the research team at carine.smitz@uza.be for enrollment information.
Where is the NCT06024993 trial being conducted?
This trial is being conducted at Edegem, Belgium.
Who is sponsoring the NCT06024993 clinical trial?
NCT06024993 is sponsored by University Hospital, Antwerp. The principal investigator is Vera Saldien, M.D., Ph.D. at Antwerp University Hospital / University of Antwerp. The trial plans to enroll 13 participants.