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RecruitingNCT06024993DeXFLoWUpdated Jan 22, 2025

Dead Space in Mechanical Ventilation With Constant Expiratory Flow

An interventional study of Flow-controlled ventilation (FCV) and Conventional volume-controlled ventilation (VCV) in Mechanical Ventilation and Artificial Respiration, sponsored by University Hospital, Antwerp. Recruiting at 1 site in Belgium. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-01-22.

Sponsored by University Hospital, Antwerp · Not applicable, Interventional, and Basic science

From the registry’s dates

  • Primary completion was expected by Dec 2025, 9 months ago, but the record still lists the study as recruiting.
  • Started Jul 2024; still recruiting 2 years 3 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
13
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

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.

02

Conditions studied

  • Mechanical Ventilation
  • Artificial Respiration
03

In context

Lead sponsor

University Hospital, Antwerp is the lead sponsor of 242 studies on the registry; 69 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
13 participants (estimated)

Study arms

  • Experimental
    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.

    Device: Flow-controlled ventilation (FCV) · Device: Conventional volume-controlled ventilation (VCV)

  • Experimental
    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.

    Device: Flow-controlled ventilation (FCV) · Device: Conventional volume-controlled ventilation (VCV)

Interventions

  • DeviceFlow-controlled ventilation (FCV)

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

  • DeviceConventional 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.

06

What researchers measure

Primary outcomes

  1. Change in Bohr dead space ventilation (VDBr/VT)

    Quantified by the Bohr approach with volumetric capnography

    Time frame: During FCV and VCV measurements (20 minutes)

Secondary outcomes

  1. Change in Enghoff dead space ventilation (VDEng/VT)

    Quantified by the Enghoff approach with volumetric capnography

    Time frame: During FCV and VCV measurements (20 minutes)

  2. Change in physiological dead space volume (Vdfys)

    Measured with volumetric capnography and Enghoff's approach

    Time frame: During FCV and VCV measurements (20 minutes)

  3. Change in airway dead space volume (Vdaw)

    Measured with volumetric capnography and Fletcher's approach

    Time frame: During FCV and VCV measurements (20 minutes)

  4. Change in alveolar dead space volume (Vdalv)

    As measured with volumetric capnography and Fletcher's approach

    Time frame: During FCV and VCV measurements (20 minutes)

  5. Ventilatory efficiency (VE/VCO2)

    Ratio of minute ventilation to carbon dioxide output

    Time frame: During FCV and VCV measurements (20 minutes)

  6. Change in airway driving pressure (∆Paw)

    Calculated as the difference between the plateau pressure (Pplat) during an inspiratory pause and the dynamic positive end-expiratory pressure (PEEP), as no expiratory hold is possible on the Evone.

    Time frame: During FCV and VCV measurements (20 minutes)

  7. Change in transpulmonary shunt fraction (Qs/Qt)

    calculated with the modified Berggren equation

    Time frame: During FCV and VCV measurements (20 minutes)

  8. Change in global lung hyperdistention (hyperdistentionEIT)

    Calculated from electric impedance tomography

    Time frame: During FCV and VCV measurements (20 minutes)

  9. Change in anterio-posterior distribution of ventilation on EIT (AP)

    % anterior / % posterior

    Time frame: During FCV and VCV measurements (20 minutes)

  10. Change in right-left distribution of ventilation on EIT (RL)

    % right / % left

    Time frame: During FCV and VCV measurements (20 minutes)

  11. Change in 4-layered distribution of ventilation on EIT

    Time frame: During FCV and VCV measurements (20 minutes)

  12. Change in centre of ventilation on EIT

    Time frame: During FCV and VCV measurements (20 minutes)

  13. Change in cardiac index (CI)

    Calculated from the arterial waveform (pulse contour analysis) by the HemoSphere monitor

    Time frame: During FCV and VCV measurements (20 minutes)

  14. Change in mean arterial pressure (MAP)

    Measured on a radial artery line

    Time frame: During FCV and VCV measurements (20 minutes)

  15. Change in partial pressure of arterial CO2 (PaCO2)

    Measured on an arterial blood gas

    Time frame: During FCV and VCV measurements (20 minutes)

  16. Change in peak expiratory flow (PEF)

    As measured by the citrex respiratory monitor

    Time frame: During FCV and VCV measurements (20 minutes)

  17. Change in peak inspiratory flow (PIF)

    As measured by the citrex respiratory monitor

    Time frame: During FCV and VCV measurements (20 minutes)

  18. Change in mean airway pressure (MPaw)

    As measured by the citrex respiratory monitor

    Time frame: During FCV and VCV measurements (20 minutes)

  19. Change in tidal volume (TV)

    As measured by the citrex respiratory monitor

    Time frame: During FCV and VCV measurements (20 minutes)

  20. Change in respiratory rate (RR)

    As measured by the citrex respiratory monitor

    Time frame: During FCV and VCV measurements (20 minutes)

  21. Change in minute ventilation (MV)

    As measured by the citrex respiratory monitor

    Time frame: During FCV and VCV measurements (20 minutes)

  22. Change in inspiratory time (Ti)

    As measured by the citrex respiratory monitor

    Time frame: During FCV and VCV measurements (20 minutes)

  23. Change in expiratory time (Te)

    As measured by the citrex respiratory monitor

    Time frame: During FCV and VCV measurements (20 minutes)

  24. Change in ratio of inspiratory time to total breath time (Ti / Tt)

    As measured by the citrex respiratory monitor

    Time frame: During FCV and VCV measurements (20 minutes)

  25. Change in positive end-expiratory pressure (PEEP)

    As measured by the citrex respiratory monitor

    Time frame: During FCV and VCV measurements (20 minutes)

  26. Change in peak inspiratory pressure (PIP)

    As measured by the citrex respiratory monitor

    Time frame: During FCV and VCV measurements (20 minutes)

  27. Change in plateau pressure (Pplat)

    As measured by the citrex respiratory monitor

    Time frame: During FCV and VCV measurements (20 minutes)

  28. Change in static airway compliance (Caw)

    Calculated as tidal volume / airway driving pressure

    Time frame: During FCV and VCV measurements (20 minutes)

  29. Change in end-tidal CO2 (ETCO2)

    As measured by the citrex respiratory monitor

    Time frame: During FCV and VCV measurements (20 minutes)

  30. Change in global airway resistance (Raw)

    As measured by the citrex respiratory monitor

    Time frame: During FCV and VCV measurements (20 minutes)

  31. Change in global airway time constant (TAUaw)

    Calculated as global airway resistance x global airway compliance

    Time frame: During FCV and VCV measurements (20 minutes)

  32. Change in total energy

    As calculated from monitoring data

    Time frame: During FCV and VCV measurements (20 minutes)

  33. Change in dissipated energy

    As calculated from monitoring data

    Time frame: During FCV and VCV measurements (20 minutes)

  34. Change in P/F ratio

    Calculated as partial pressure of arterial oxygen divided by inspiratory fraction of oxygen

    Time frame: During FCV and VCV measurements (20 minutes)

07

Study locations

1 of 1 sites recruiting
  • Antwerp University Hospital (UZA)
    Edegem, Antwerp 2650, Belgium
    • Carine Smitz · Contact · carine.smitz@uza.be · +323 821 49 30
    • Tom Schepens, M.D., Ph.D. · Sub investigator
    • Philippe G Jorens, M.D., Ph.D. · Sub investigator
    • Gregory R De Meyer, M.D. · Sub investigator
    • Vincent Vandebergh, M.D. · Sub investigator
    • Stuart G Morrison, M.D. · Sub investigator
    • Vera Saldien, M.D., Ph.D. · Principal investigator
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 22, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06024993
Responsible party
Sponsor
First posted
Sep 6, 2023
Start date
Jul 22, 2024
Primary completion
Dec 30, 2025 (estimated)
Completion
Apr 30, 2026 (estimated)
Last update
Jan 22, 2025

Study contacts

Carine Smitz
Contact
carine.smitz@uza.be
+32 3 821 49 30
Joke De Wachter
Contact
joke.dewachter@uza.be
+32 3 821 30 42
Vera Saldien, M.D., Ph.D.
principal investigator · Antwerp University Hospital / University of Antwerp

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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