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

Respiration, Artificial Clinical Trial

— VICAR  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04894214
• Other study ID #: 001533
• Secondary ID: 001533
• Status: Completed
• Start date: January 11, 2021
• Est. completion date: May 1, 2021

Study information

• Verified date: February 2022
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: May 1, 2021
• Est. primary completion date: April 23, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• COVID-19
• Respiration, Artificial
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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.
• 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.

Locations

Country	Name	City	State
Belgium	Antwerp University Hospital	Edegem	Antwerp

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Antwerp

Country where clinical trial is conducted

Belgium, 

Outcome

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