COVID-19 Acute Respiratory Distress SyndromeVICARNCT04894214
Flow-controlled Ventilation (FCV) in Moderate Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19
An observational study of COVID-19 Acute Respiratory Distress Syndrome and Respiration, Artificial, run by University Hospital, Antwerp at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- COVID-19 Acute Respiratory Distress Syndrome, Respiration, Artificial
- What is being tested?
- Arterial blood gas (ABG), Recording of hemodynamic monitoring and Recording of respiratory monitoring
- How many people
- 11 participants
- Where
- 1 siteBelgium
- Study dates
- 11 Jan 2021to 1 May 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients requiring mechanical ventilation for moderately severe ARDS (P/F ratio 100-200) due to COVID-19 were recruited from a tertiary intensive care unit.
Who may be able to join
- P/F-ratio: 100-200 (moderate ARDS)
- SpO2 88-94%
- PaO2 60-80 mmHg
- COVID-19 positive on a PCR test
Who cannot join
- BMI > 40 kg/m²
- Prone ventilation
- Already invasively mechanically ventilated for more than 10 days
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Flow-controlled Ventilation (FCV) in Moderate Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 - an Interventional Cross-over Study
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.
- Being tested
- Arterial blood gas (ABG), Recording of hemodynamic monitoring, Recording of respiratory monitoring
- Keywords
- Flow controlled ventilation (FCV)
- Medical subject headings
- Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial blood gas (ABG)Diagnostic test
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.
Recording of hemodynamic monitoringOther
Hemodynamic parameters (invasive arterial blood pressure (mmHg) and heart rate (beats per minute)) will be recorded every 5 minutes.
Recording of respiratory monitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Arterial blood gas (ABG); Other: Recording of hemodynamic monitoring; Other: Recording of respiratory monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterial oxygen tension, PaO2 (mmHg)
Arterial partial oxygen tension as measured on an arterial blood gas sample.
Measured: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
P/F ratio or Horowitz index (mmHg)
Ratio of the arterial oxygen tension PaO2 (mmHg) divided by the inspiratory fraction of oxygen FiO2.
Measured: Post hoc calculation
Secondary outcomes (14)
SpO2 (%)
Oxygen saturation as measured by pulse oxymetry.
Measured: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
FiO2
Fraction of inspired oxygen as measured by the respirator.
Measured: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
PEEP (cmH2O)
Positive end-expiratory pressure as measured by the respirator.
Measured: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
Pmean
Mean airway pressure (cmH2O) as measured by the respirator.
Measured: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
PaCO2
Arterial partial tension of carbon dioxide (mmHg) as measured on an arterial blood gas sample.
Measured: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
MV
Minute volume (l/min) as measured by the respirator.
Measured: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
TV
Tidal volume (ml) as measured by the respirator.
Measured: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
RR
Respiratory rate (breaths per minute) as measured by the respirator.
Measured: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
Pplat
Plateau airway pressure (cmH2O) as measured by the respirator
Measured: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
PIP
Peak inspiratory airway pressure (cmH2O) as measured by the respirator.
Measured: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
ABPsys
Systolic arterial blood pressure (mmHg) as measured by a pressure transducer on an arterial catheter.
Measured: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
ABPmean
Mean arterial blood pressure (mmHg) as measured by a pressure transducer on an arterial catheter.
Measured: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
ABPdia
Diastolic arterial blood pressure (mmHg) as measured by a pressure transducer on an arterial catheter.
Measured: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
HR
Heart rate (beats per minute) as measured on a 5-lead continuous electrocardiogram.
Measured: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start11 Jan 2021
- Primary completion23 Apr 2021
- Study completion1 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19 Acute Respiratory Distress SyndromeStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Prospective
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tom Schepens, MD, University Hospital, Antwerp
- Investigators
- Tom Schepens, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04894214
- Sponsor's protocol ID
- 001533
- Other IDs
- 001533
- Acronym
- VICAR
- Status last verified
- Feb 2022
- First submitted
- 17 May 2021
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Van Dessel ED, De Meyer GR, Morrison SG, Jorens PG, Schepens T. Flow-controlled ventilation in moderate acute respiratory distress syndrome due to COVID-19: an open-label repeated-measures controlled trial. Intensive Care Med Exp. 2022 May 24;10(1):19. doi: 10.1186/s40635-022-00449-4.
PubMed 35608696
Study at a glance
From the registry record, last updated by the sponsor on 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow-controlled Ventilation (FCV) in Moderate Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 - an Interventional Cross-over Study
- ClinicalTrials.gov ID
- NCT04894214
- Acronym / sponsor ID
- VICAR / 001533
- Keywords
- Flow controlled ventilation (FCV)
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 23 Apr 2021 (actual)
- Study completion
- 1 May 2021 (actual)
- First posted
- 20 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sequential "baseline PCV" - "FCV" - "VCV" | – | Diagnostic Test: Arterial blood gas (ABG), Other: Recording of hemodynamic monitoring, Other: Recording of respiratory monitoringEach 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients requiring mechanical ventilation for moderately severe ARDS (P/F ratio 100-200) due to COVID-19 were recruited from a tertiary intensive care unit.
Key inclusion criteria (4 listed)
- P/F-ratio: 100-200 (moderate ARDS)
- SpO2 88-94%
- PaO2 60-80 mmHg
- COVID-19 positive on a PCR test
Key exclusion criteria (4 listed)
- BMI > 40 kg/m²
- Prone ventilation
- Already invasively mechanically ventilated for more than 10 days
- Refusal to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Sequential "baseline PCV" - "FCV" - "VCV" |
| Recording of hemodynamic monitoringHemodynamic parameters (invasive arterial blood pressure (mmHg) and heart rate (beats per minute)) will be recorded every 5 minutes. | Other | Sequential "baseline PCV" - "FCV" - "VCV" |
| Recording of respiratory monitoringTidal 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. | Other | Sequential "baseline PCV" - "FCV" - "VCV" |
Primary outcome
Arterial oxygen tension, PaO2 (mmHg)
Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
Arterial partial oxygen tension as measured on an arterial blood gas sample.
P/F ratio or Horowitz index (mmHg)
Time frame: Post hoc calculation
Ratio of the arterial oxygen tension PaO2 (mmHg) divided by the inspiratory fraction of oxygen FiO2.
14 secondary outcomes
SpO2 (%)
Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
FiO2
Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
PEEP (cmH2O)
Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
Pmean
Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
PaCO2
Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
MV
Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
TV
Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
RR
Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
Pplat
Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
PIP
Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
ABPsys
Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
ABPmean
Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
ABPdia
Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
HR
Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 2022.
- Derived from this study: PubMed 35608696Van Dessel ED, De Meyer GR, Morrison SG, Jorens PG, Schepens T. Flow-controlled ventilation in moderate acute respiratory distress syndrome due to COVID-19: an open-label repeated-measures controlled trial. Intensive Care Med Exp. 2022 May 24;10(1):19. doi: 10.1186/s40635-022-00449-4.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tom Schepens, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 Acute Respiratory Distress Syndrome and Respiration, Artificial, run by University Hospital, Antwerp at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arterial oxygen tension, PaO2 (mmHg) (time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04894214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Feb 2022; AzTrials last refreshed its copy on 8 Nov 2026.