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

NCT ID: NCT04894214

Last Updated: 2022-02-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 11 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-11
• Study Completion Date: 2021-05-01

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.

Conditions

COVID-19 Acute Respiratory Distress Syndrome; Respiration, Artificial

Study Design

• Observational Model Type: CASE_CROSSOVER
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Arterial blood gas (ABG)

Intervention Type: 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 monitoring

Intervention Type: OTHER

Hemodynamic parameters (invasive arterial blood pressure (mmHg) and heart rate (beats per minute)) will be recorded every 5 minutes.

Recording of respiratory monitoring

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Recording of hemodynamic monitoring

Hemodynamic parameters (invasive arterial blood pressure (mmHg) and heart rate (beats per minute)) will be recorded every 5 minutes.

Intervention Type: 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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Antwerp

OTHER

Sponsor Role: lead

Responsible Party

Tom Schepens, MD

Principal investigator, Member of staff at the department of critical care, Doctor of Philosophy, Medical Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tom Schepens, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Antwerp

Locations

Antwerp University Hospital

Edegem, Antwerp, Belgium

Countries

Belgium

References

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.

Reference Type: DERIVED

PMID: 35608696 (View on PubMed)

Other Identifiers

001533

Identifier Type: OTHER

Identifier Source: secondary_id

001533

Identifier Type: -

Identifier Source: org_study_id