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

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.

Study Overview

• Status: Completed
• Conditions: Respiration, Artificial; COVID-19 Acute Respiratory Distress Syndrome
• Intervention / Treatment: Diagnostic test: Arterial blood gas (ABG); Other: Recording of hemodynamic monitoring; Other: Recording of respiratory monitoring

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• Belgium
  • Antwerp
    • Edegem, Antwerp, Belgium, 2650
      • Antwerp University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial oxygen tension, PaO2 (mmHg)	Arterial partial oxygen tension as measured on an arterial blood gas sample.	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.	Post hoc calculation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
SpO2 (%)	Oxygen saturation as measured by pulse oxymetry.	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
FiO2	Fraction of inspired oxygen as measured by the respirator.	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
PEEP (cmH2O)	Positive end-expiratory pressure as measured by the respirator.	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
Pmean	Mean airway pressure (cmH2O) as measured by the respirator.	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.	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
MV	Minute volume (l/min) as measured by the respirator.	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
TV	Tidal volume (ml) as measured by the respirator.	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
RR	Respiratory rate (breaths per minute) as measured by the respirator.	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
Pplat	Plateau airway pressure (cmH2O) as measured by the respirator	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)
PIP	Peak inspiratory airway pressure (cmH2O) as measured by the respirator.	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.	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.	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.	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.	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)

Collaborators and Investigators

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

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 11, 2021
• Primary Completion (Actual): April 23, 2021
• Study Completion (Actual): May 1, 2021

Study Registration Dates

• First Submitted: May 17, 2021
• First Submitted That Met QC Criteria: May 19, 2021
• First Posted (Actual): May 20, 2021

Study Record Updates

• Last Update Posted (Actual): February 3, 2022
• Last Update Submitted That Met QC Criteria: February 2, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Flow controlled ventilation (FCV)
• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Respiration Disorders; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease; Infant, Newborn, Diseases; Lung Injury; Infant, Premature, Diseases; COVID-19; Syndrome; Respiratory Distress Syndrome; Respiratory Distress Syndrome, Newborn; Acute Lung Injury
• Other Study ID Numbers: 001533 (Other Identifier: EDGE)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No