VICAR: Flow-controlled Ventilation (FCV) in Moderate Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19

Sponsor
University Hospital, Antwerp (Other)
Overall Status
Completed
CT.gov ID
NCT04894214
Collaborator
(none)
11
1
3.6
3

Study Details

Study Description

Brief Summary

Flow controlled ventilation (FCV) is a fairly new mode of mechanical ventilation, consisting of a constant inspiratory and expiratory flow. Inspiration is thus comparable to volume controlled ventilation (VCV). The actively controlled, constant flow during expiration is unique. FCV is known to minimize dissipated energy to the lung [ref] and is therefore supposed to aid in lung protective ventilation.

The VICAR study is designed as a prospective single cohort crossover trial. The intervention consists of a sequence of respiratory modes: baseline pressure controlled ventilation (PCV) during 5 minutes, followed by 30 minutes of FCV with an evone respirator (Ventinova Medical B.V., Eindhoven, The Netherlands) and eventually 30 minutes of VCV. Every participant will receive the intervention. Respiratory rate (RR), positive end-expiratory pressure (PEEP) and inspiratory fraction of oxygen (FiO2) will be held constant. According to the manufacturers guidelines, an I:E ratio of 1:1 will be pursued during FCV. During FCV, the respirator will be set with the same PIP as during baseline PCV. For VCV, the same tidal volume as during baseline PCV will be set.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Arterial blood gas (ABG)
  • Other: Recording of hemodynamic monitoring
  • Other: Recording of respiratory monitoring

Study Design

Study Type:
Observational
Actual Enrollment :
11 participants
Observational Model:
Case-Crossover
Time Perspective:
Prospective
Official Title:
Flow-controlled Ventilation (FCV) in Moderate Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 - an Interventional Cross-over Study
Actual Study Start Date :
Jan 11, 2021
Actual Primary Completion Date :
Apr 23, 2021
Actual Study Completion Date :
May 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Sequential "baseline PCV" - "FCV" - "VCV"

Each participant will be subjected to baseline pressure controlled ventilation (PCV) during 5 minutes, followed by 30 minutes of FCV with an evone respirator (Ventinova Medical B.V., Eindhoven, The Netherlands) and eventually 30 minutes of VCV. Respiratory rate (RR), positive end-expiratory pressure (PEEP) and inspiratory fraction of oxygen (FiO2) will be held constant. According to the manufacturers guidelines, an I:E ratio of 1:1 will be pursued during FCV. During FCV, the respirator will be set with the same PIP as during baseline PCV. For VCV, the same tidal volume as during baseline PCV will be set.

Diagnostic Test: Arterial blood gas (ABG)
Arterial blood gasses will be drawn during baseline PCV, and every 15 minutes during FCV and VCV respectively. pO2 (mmHg), pCO2 (mmHg) and pH will be recorded.

Other: Recording of hemodynamic monitoring
Hemodynamic parameters (invasive arterial blood pressure (mmHg) and heart rate (beats per minute)) will be recorded every 5 minutes.

Other: Recording of respiratory monitoring
Tidal volume (ml), respiratory rate (breaths per minute), minute volume (l/min), dynamic compliance (ml/cmH2O), resistance (cmH2O/l/min), plateau pressure (cmH2O), mean airway pressure (cmH2O), positive end-expiratory pressure (cmH2O), peak inspiratory pressure (cmH2O) and fraction of inspired oxygen will be recorded every 5 minutes.

Outcome Measures

Primary Outcome Measures

  1. Arterial oxygen tension, PaO2 (mmHg) [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]

    Arterial partial oxygen tension as measured on an arterial blood gas sample.

  2. P/F ratio or Horowitz index (mmHg) [Post hoc calculation]

    Ratio of the arterial oxygen tension PaO2 (mmHg) divided by the inspiratory fraction of oxygen FiO2.

Secondary Outcome Measures

  1. SpO2 (%) [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]

    Oxygen saturation as measured by pulse oxymetry.

  2. FiO2 [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]

    Fraction of inspired oxygen as measured by the respirator.

  3. PEEP (cmH2O) [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]

    Positive end-expiratory pressure as measured by the respirator.

  4. Pmean [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]

    Mean airway pressure (cmH2O) as measured by the respirator.

  5. PaCO2 [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]

    Arterial partial tension of carbon dioxide (mmHg) as measured on an arterial blood gas sample.

  6. MV [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]

    Minute volume (l/min) as measured by the respirator.

  7. TV [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]

    Tidal volume (ml) as measured by the respirator.

  8. RR [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]

    Respiratory rate (breaths per minute) as measured by the respirator.

  9. Pplat [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]

    Plateau airway pressure (cmH2O) as measured by the respirator

  10. PIP [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]

    Peak inspiratory airway pressure (cmH2O) as measured by the respirator.

  11. ABPsys [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]

    Systolic arterial blood pressure (mmHg) as measured by a pressure transducer on an arterial catheter.

  12. ABPmean [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]

    Mean arterial blood pressure (mmHg) as measured by a pressure transducer on an arterial catheter.

  13. ABPdia [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]

    Diastolic arterial blood pressure (mmHg) as measured by a pressure transducer on an arterial catheter.

  14. HR [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]

    Heart rate (beats per minute) as measured on a 5-lead continuous electrocardiogram.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • P/F-ratio: 100-200 (moderate ARDS)

  • SpO2 88-94%

  • PaO2 60-80 mmHg

  • COVID-19 positive on a PCR test

Exclusion Criteria:
  • BMI > 40 kg/m²

  • Prone ventilation

  • Already invasively mechanically ventilated for more than 10 days

  • Refusal to participate

Contacts and Locations

Locations

Site City State Country Postal Code
1 Antwerp University Hospital Edegem Antwerp Belgium 2650

Sponsors and Collaborators

  • University Hospital, Antwerp

Investigators

  • Principal Investigator: Tom Schepens, MD, PhD, University Hospital, Antwerp

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Tom Schepens, MD, Principal investigator, Member of staff at the department of critical care, Doctor of Philosophy, Medical Doctor, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT04894214
Other Study ID Numbers:
  • 001533
  • 001533
First Posted:
May 20, 2021
Last Update Posted:
Feb 3, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Tom Schepens, MD, Principal investigator, Member of staff at the department of critical care, Doctor of Philosophy, Medical Doctor, University Hospital, Antwerp
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 3, 2022