Dead Space in Mechanical Ventilation With Constant Expiratory Flow

NCT ID: NCT06024993

Last Updated: 2025-01-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-22
• Study Completion Date: 2026-04-30

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.

Conditions

Mechanical Ventilation; Artificial Respiration

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: DOUBLE

Study Groups

FCV-VCV

After titration of ventilation in baseline VCV (all arms), participants will first receive 20 min of baseline-matched FCV and subsequently 20 min of baseline-matched VCV.

Group Type: EXPERIMENTAL

Flow-controlled ventilation (FCV)

Intervention Type: DEVICE

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

Conventional volume-controlled ventilation (VCV)

Intervention Type: DEVICE

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

VCV-FCV

After titration of ventilation in baseline VCV (all arms), participants will first receive 20 min of baseline-matched VCV and subsequently 20 min of baseline-matched FCV.

Group Type: EXPERIMENTAL

Flow-controlled ventilation (FCV)

Intervention Type: DEVICE

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

Conventional volume-controlled ventilation (VCV)

Intervention Type: DEVICE

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

Interventions

Flow-controlled ventilation (FCV)

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

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universiteit Antwerpen

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vera Saldien, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Antwerp University Hospital / University of Antwerp

Locations

Antwerp University Hospital (UZA)

Edegem, Antwerp, Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Carine Smitz

Role: CONTACT

carine.smitz@uza.be

+32 3 821 49 30

Joke De Wachter

Role: CONTACT

joke.dewachter@uza.be

+32 3 821 30 42

Facility Contacts

Carine Smitz

Role: primary

carine.smitz@uza.be

+323 821 49 30

Other Identifiers

003029

Identifier Type: -

Identifier Source: org_study_id