Clinical trial NCT04386369: Evaluation of Airway Pressure Release Ventilation in COVID-19 ARDS
Official title: Evaluation of Airway Pressure Release Ventilation on Oxygenation in Acute Respiratory Distress Syndrome in Adult Patients With COVID-19 Pneumonia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ARDS
COVID19
Keywords: Airway Pressure Release Ventilation
Intensive Care Unit
SARS-CoV-2
APRV
Acute respiratory failure
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2020-05-13
Enrollment: 17
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients admitted to the Intensive Care Unit for treatment of COVID-19 related acute respiratory failure.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of patients improving PaO2/FiO2 ratio at 6 hours of APRV
timeFrame: 6 hours after starting APRV
Secondary outcomes:
measure: Number of interventions on ventilator settings
timeFrame: 6 hours after starting APRV
measure: Change in mean blood pressure
timeFrame: 6 hours after starting APRV
measure: Change in heart rate
timeFrame: 6 hours after starting APRV
measure: Changes in catecholamine doses
timeFrame: 6 hours after starting APRV
measure: Changes in static compliance at the end of 6 hours of APRV
timeFrame: 6 hours after starting APRV
measure: Variations of minute ventilation
timeFrame: 6 hours after starting APRV
measure: Changes in static compliance 4 hours after stopping APRV
timeFrame: 4 hours after starting APRV
measure: Proportion of patients with a decrease of the PaO2/FiO2 ratio
timeFrame: 4 hours after stopping APRV
Other outcomes:
Locations:
city: Nancy
country: France
facility: Centre Hospitalier Régional Universitaire de Nancy
Study officials:
affiliation: CHRU de NANCY, Médecine Intensive et Réanimation Brabois
name: Matthieu Koszutski, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.