Evaluation of Airway Pressure Release Ventilation in COVID-19 ARDS

Completed

• Conditions: COVID19; ARDS
• Interventions: Other: Airway pressure release ventilation

• Registration Number: NCT04386369
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

The 2020 pandemic of the coronavirus (SARS-CoV2) has lead to an increase in ARDS cases requiring invasive mechanical ventilation in the ICU (Intensive Care Unit).

The investigators hypothesize that airway pressure release ventilation (APRV) could be beneficial in patients with ARDS secondary to SARS-COV2 viral pneumonia.

Detailed Description

Lung protective mechanical ventilation is the cornerstone of ARDS management, reducing the work of respiratory muscles and optimizing gas exchange. However, it can be the source of deleterious effects, grouped under the terms of ventilator induced lung injury (VILI) and ventilator induced diaphragm dysfunction.

The protective ventilatory strategy has led to a significant improvement in the prognosis of ARDS patients, by reducing the volume of the air and oxygen mixture (lower tidal volume) delivered to the lungs and thus reducing the pulmonary stress and strain. However, this protective ventilation usually requires deep sedation and neuromuscular blockade to avoid deleterious patient-ventilator asynchrony.

Airway Pressure Release Ventilation (APRV) has been proposed to reduce patient-ventilator asynchrony and reduce the VILI. The operating principles of APRV are based on the presence of two pressure levels that are kept constant. Spontaneous breathing is possible at any time at both pressure levels if the patient is not deeply sedated or under neuromuscular blockade.

The investigators hypothesize that APRV mode could be beneficial on oxygenation and respiratory work in patients with ARDS secondary to SARS-COV2 viral pneumonia.

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-14
• Study Start: 2020-04-15
• Study First Submitted QC: 2020-05-12
• Study First Posted: 2020-05-13
• Primary Completion: 2020-06-01
• Study Completion: 2020-06-01
• Last Update Submitted: 2020-09-10
• Last Update Posted: 2020-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

Inclusion Criteria

• Patients treated in Nancy University Hospital between 01/04/2020 and 31/06/2020 for COVID-19 ARDS, requiring invasive ventilation
• Trial of airway pressure release ventilation during the ICU stay

Exclusion Criteria

• Patients requiring veno-venous ECMO
• Patients unable to complete the 6-hour APRV trial due to poor tolerance : SpO2 decrease < 90% on FiO2 70%, haemodynamic instability (MAP < 65mmhg without vasopressors, or 0.5 mg/h increase in norepinephrine, ventilator asynchrony (respiratory rate >35), hypercapnia (pH < 7,25 or PaCO2 >60mmHg)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Airway Pressure Release Ventilation	Airway pressure release ventilation	Patients with COVID-19 ARDS requiring invasive mechanical ventilation in ICU, on Volume Assist Control ventilation (VAC) or Pressure Assist Control (PAC), are switched to airway pressure ventilation (APRV). If APRV doesn't lead to improvement in oxygenation the ventilatory mode is switched back to VAC or PAC ventilatory mode.

Primary Outcome Measures

Name	Time	Method
Proportion of patients improving PaO2/FiO2 ratio at 6 hours of APRV	6 hours after starting APRV	Increase of at least 20% of the PaO2/FiO2 ratio

Secondary Outcome Measures

Name	Time	Method
Number of interventions on ventilator settings	6 hours after starting APRV	Number of interventions by the physician on APRV settings
Change in mean blood pressure	6 hours after starting APRV	Variations of blood pressure in millimeters of mercury
Change in heart rate	6 hours after starting APRV	Variations of heart rate in beats per minute
Changes in catecholamine doses	6 hours after starting APRV	Variations of catecholamine doses in milligrams per hours
Changes in static compliance at the end of 6 hours of APRV	6 hours after starting APRV	Static compliance (Cstat) defined as : Cstat = (VT/(Pplat-PEPtot)) Tidal Volume (VT), Plateau pressure (Pplat) and Total Positive End-expiratory Pressure (PEEPtot)
Variations of minute ventilation	6 hours after starting APRV	Minute ventilation in liters per minute
Changes in static compliance 4 hours after stopping APRV	4 hours after starting APRV	Static compliance (Cstat) defined as : Cstat = (VT/(Pplat-PEPtot)) Tidal Volume (VT), Plateau pressure (Pplat) and Total Positive End-expiratory Pressure (PEEPtot)
Proportion of patients with a decrease of the PaO2/FiO2 ratio	4 hours after stopping APRV	Percentage of patients with a decrease of the PaO2/FiO2 ratio

Trial Locations

Locations (1)

Centre Hospitalier Régional Universitaire de Nancy; 🇫🇷 Nancy, France