Clinical trial NCT04894214: Flow-controlled Ventilation (FCV) in Moderate Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19
Official title: Flow-controlled Ventilation (FCV) in Moderate Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 - an Interventional Cross-over Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19 Acute Respiratory Distress Syndrome
Respiration, Artificial
Keywords: Flow controlled ventilation (FCV)
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
First posted: 2021-05-20
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Arterial oxygen tension, PaO2 (mmHg)
timeFrame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
measure: P/F ratio or Horowitz index (mmHg)
timeFrame: Post hoc calculation
Secondary outcomes:
measure: SpO2 (%)
timeFrame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
measure: FiO2
timeFrame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
measure: PEEP (cmH2O)
timeFrame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
measure: Pmean
timeFrame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
measure: PaCO2
timeFrame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
measure: MV
timeFrame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
measure: TV
timeFrame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
measure: RR
timeFrame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
measure: Pplat
timeFrame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
measure: PIP
timeFrame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
measure: ABPsys
timeFrame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
measure: ABPmean
timeFrame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
measure: ABPdia
timeFrame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
measure: HR
timeFrame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: Antwerp University Hospital
state: Antwerp
Study officials:
affiliation: University Hospital, Antwerp
name: Tom Schepens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.