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Completed

NCT Number: NCT04894214

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

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.

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Key information

Conditions

COVID-19 Acute Respiratory Distress Syndrome Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiration, Artificial Respiratory Aspiration Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 monitoring

Other

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

Recording of respiratory monitoring

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. SpO2 (%)

    Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)

    Oxygen saturation as measured by pulse oxymetry.

  2. FiO2

    Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)

    Fraction of inspired oxygen as measured by the respirator.

  3. PEEP (cmH2O)

    Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)

    Positive end-expiratory pressure as measured by the respirator.

  4. Pmean

    Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)

    Mean airway pressure (cmH2O) as measured by the respirator.

  5. PaCO2

    Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)

    Arterial partial tension of carbon dioxide (mmHg) as measured on an arterial blood gas sample.

  6. MV

    Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)

    Minute volume (l/min) as measured by the respirator.

  7. TV

    Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)

    Tidal volume (ml) as measured by the respirator.

  8. RR

    Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)

    Respiratory rate (breaths per minute) as measured by the respirator.

  9. Pplat

    Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)

    Plateau airway pressure (cmH2O) as measured by the respirator

  10. PIP

    Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)

    Peak inspiratory airway pressure (cmH2O) as measured by the respirator.

  11. ABPsys

    Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)

    Systolic arterial blood pressure (mmHg) as measured by a pressure transducer on an arterial catheter.

  12. ABPmean

    Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)

    Mean arterial blood pressure (mmHg) as measured by a pressure transducer on an arterial catheter.

  13. ABPdia

    Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)

    Diastolic arterial blood pressure (mmHg) as measured by a pressure transducer on an arterial catheter.

  14. HR

    Time frame: Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)

    Heart rate (beats per minute) as measured on a 5-lead continuous electrocardiogram.

Sponsors and collaborators

Lead sponsor

University Hospital, Antwerp

Other

Registry information

Official study title

Flow-controlled Ventilation (FCV) in Moderate Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19 - an Interventional Cross-over Study

Acronym: VICAR

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 20, 2021
Registry last updated
Feb 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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