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

A

Antwerp University Hospital (UZA)

Status

Completed

Conditions

COVID-19 Acute Respiratory Distress Syndrome
Respiration, Artificial

Treatments

Diagnostic Test: Arterial blood gas (ABG)
Other: Recording of respiratory monitoring
Other: Recording of hemodynamic monitoring

Study type

Observational

Funder types

Other

Identifiers

NCT04894214
001533 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

11 patients

Sex

All

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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

Trial design

11 participants in 1 patient group

Sequential "baseline PCV" - "FCV" - "VCV"
Description:
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.
Treatment:
Other: Recording of respiratory monitoring
Diagnostic Test: Arterial blood gas (ABG)
Other: Recording of hemodynamic monitoring

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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