Evaluation of Airway Pressure Release Ventilation in COVID-19 ARDS (APRV-COVID19)

Evaluation of Airway Pressure Release Ventilation on Oxygenation in Acute Respiratory Distress Syndrome in Adult Patients With COVID-19 Pneumonia

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.

Study Overview

• Status: Completed
• Conditions: ARDS; COVID19
• Intervention / Treatment: Other: Airway pressure release ventilation

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 Type: Observational
• Enrollment (Actual): 17

Contacts and Locations

Study Locations

• France
  • Nancy, France, 54500
    • Centre Hospitalier Régional Universitaire de Nancy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients admitted to the Intensive Care Unit for treatment of COVID-19 related acute respiratory failure.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Other: Airway pressure release ventilation; Ventilator management strategy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients improving PaO2/FiO2 ratio at 6 hours of APRV	Increase of at least 20% of the PaO2/FiO2 ratio	6 hours after starting APRV

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Matthieu Koszutski, MD, CHRU de NANCY, Médecine Intensive et Réanimation Brabois

Publications and helpful links

General Publications

• Zhou Y, Jin X, Lv Y, Wang P, Yang Y, Liang G, Wang B, Kang Y. Early application of airway pressure release ventilation may reduce the duration of mechanical ventilation in acute respiratory distress syndrome. Intensive Care Med. 2017 Nov;43(11):1648-1659. doi: 10.1007/s00134-017-4912-z. Epub 2017 Sep 22.
• Nieman GF, Al-Khalisy H, Kollisch-Singule M, Satalin J, Blair S, Trikha G, Andrews P, Madden M, Gatto LA, Habashi NM. A Physiologically Informed Strategy to Effectively Open, Stabilize, and Protect the Acutely Injured Lung. Front Physiol. 2020 Mar 19;11:227. doi: 10.3389/fphys.2020.00227. eCollection 2020.

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2020
• Primary Completion (Actual): June 1, 2020
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: April 14, 2020
• First Submitted That Met QC Criteria: May 12, 2020
• First Posted (Actual): May 13, 2020

Study Record Updates

• Last Update Posted (Actual): September 14, 2020
• Last Update Submitted That Met QC Criteria: September 10, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: SARS-CoV-2; Intensive Care Unit; Airway Pressure Release Ventilation; APRV; Acute respiratory failure
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: 2020PI076

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No