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

Completed

• Conditions: Respiration, Artificial; COVID-19 Acute Respiratory Distress Syndrome
• Interventions: Diagnostic Test: Arterial blood gas (ABG); Other: Recording of hemodynamic monitoring; Other: Recording of respiratory monitoring

• Registration Number: NCT04894214
• Lead Sponsor: University Hospital, Antwerp

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-01-11
• Primary Completion: 2021-04-23
• Study Completion: 2021-05-01
• Study First Submitted: 2021-05-17
• Study First Submitted QC: 2021-05-19
• Study First Posted: 2021-05-20
• Status Verified: 2022-02
• Last Update Submitted: 2022-02-02
• Last Update Posted: 2022-02-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Sequential "baseline PCV" - "FCV" - "VCV"	Arterial blood gas (ABG)	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.
Sequential "baseline PCV" - "FCV" - "VCV"	Recording of hemodynamic monitoring	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.
Sequential "baseline PCV" - "FCV" - "VCV"	Recording of respiratory monitoring	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.

Primary Outcome Measures

Name	Time	Method
Arterial oxygen tension, PaO2 (mmHg)	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)	Arterial partial oxygen tension as measured on an arterial blood gas sample.
P/F ratio or Horowitz index (mmHg)	Post hoc calculation	Ratio of the arterial oxygen tension PaO2 (mmHg) divided by the inspiratory fraction of oxygen FiO2.

Secondary Outcome Measures

Name	Time	Method
PaCO2	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.
Pplat	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)	Plateau airway pressure (cmH2O) as measured by the respirator
PIP	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)	Peak inspiratory airway pressure (cmH2O) as measured by the respirator.
ABPsys	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.
TV	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)	Tidal volume (ml) as measured by the respirator.
ABPdia	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.
SpO2 (%)	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)	Oxygen saturation as measured by pulse oxymetry.
RR	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)	Respiratory rate (breaths per minute) as measured by the respirator.
PEEP (cmH2O)	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)	Positive end-expiratory pressure as measured by the respirator.
Pmean	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)	Mean airway pressure (cmH2O) as measured by the respirator.
FiO2	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)	Fraction of inspired oxygen as measured by the respirator.
MV	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)	Minute volume (l/min) as measured by the respirator.
ABPmean	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.
HR	Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)	Heart rate (beats per minute) as measured on a 5-lead continuous electrocardiogram.

Trial Locations

Locations (1)

Antwerp University Hospital; 🇧🇪 Edegem, Antwerp, Belgium