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

NCT04894214 | Completed

• 1 other identifier: 001533
• Study Type: observational
• Target: 11
• Locations: 1 country
• Sites: 1

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

Keywords

Flow controlled ventilation (FCV)

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (14)

• SpO2 (%)

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

• FiO2

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

• PEEP (cmH2O)

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

• Pmean

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

• PaCO2

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

Study Arms (1)

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.

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

Interventions

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.

Sequential "baseline PCV" - "FCV" - "VCV"

Recording of hemodynamic monitoring OTHER

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

Sequential "baseline PCV" - "FCV" - "VCV"

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.

Sequential "baseline PCV" - "FCV" - "VCV"

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients requiring mechanical ventilation for moderately severe ARDS (P/F ratio 100-200) due to COVID-19 were recruited from a tertiary intensive care unit.

You may qualify if:

• P/F-ratio: 100-200 (moderate ARDS)
• SpO2 88-94%
• PaO2 60-80 mmHg
• COVID-19 positive on a PCR test

You may not qualify if:

• BMI \> 40 kg/m²
• Prone ventilation
• Already invasively mechanically ventilated for more than 10 days
• Refusal to participate

Sponsors & Collaborators

• University Hospital, Antwerp: lead

Study Sites (1)

Antwerp University Hospital

Edegem, Antwerp, 2650, Belgium

Location

Related Publications (1)

• 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.

  PMID: 35608696 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Point-of-care arterial blood gas sampling. The sample will be disposed as biohazard material after analysis is done.

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Tom Schepens, MD, PhD

  University Hospital, Antwerp

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, Member of staff at the department of critical care, Doctor of Philosophy, Medical Doctor

Study Record Dates

• First Submitted: May 17, 2021
• First Posted: May 20, 2021
• Study Start: January 11, 2021
• Primary Completion: April 23, 2021
• Study Completion: May 1, 2021
• Last Updated: February 3, 2022

Record last verified: 2022-02

Locations

BE (1)