VICAR: Flow-controlled Ventilation (FCV) in Moderate Acute Respiratory Distress Syndrome (ARDS) Due to COVID-19
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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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)
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.
Other: 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.
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Outcome Measures
Primary Outcome Measures
- 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
- SpO2 (%) [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]
Oxygen saturation as measured by pulse oxymetry.
- FiO2 [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]
Fraction of inspired oxygen 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.
- 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.
- MV [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]
Minute volume (l/min) as measured by the respirator.
- TV [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]
Tidal volume (ml) as measured by the respirator.
- RR [Approximately 1 hour (5 min. PCV + 30min. FCV + 30 min. VCV)]
Respiratory rate (breaths per minute) as measured by the respirator.
- 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.
- 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.
- 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.
- 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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P/F-ratio: 100-200 (moderate ARDS)
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SpO2 88-94%
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PaO2 60-80 mmHg
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COVID-19 positive on a PCR test
Exclusion Criteria:
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BMI > 40 kg/m²
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Prone ventilation
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Already invasively mechanically ventilated for more than 10 days
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Refusal to participate
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
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1 | Antwerp University Hospital | Edegem | Antwerp | Belgium | 2650 |
Sponsors and Collaborators
- University Hospital, Antwerp
Investigators
- Principal Investigator: Tom Schepens, MD, PhD, University Hospital, Antwerp
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 001533
- 001533