Evaluation of Airway Pressure Release Ventilation in COVID-19 ARDS

COVID19 Clinical Trial

— APRV-COVID19  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386369
• Other study ID #: 2020PI076
• Status: Completed
• Start date: April 15, 2020
• Est. completion date: June 1, 2020

Study information

• Verified date: April 2020
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: June 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• ARDS
• COVID19

Intervention

Other:
• Airway pressure release ventilation
Ventilator management strategy

Locations

Country	Name	City	State
France	Centre Hospitalier Régional Universitaire de Nancy	Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of interventions on ventilator settings	Number of interventions by the physician on APRV settings	6 hours after starting APRV
Secondary	Change in mean blood pressure	Variations of blood pressure in millimeters of mercury	6 hours after starting APRV
Secondary	Change in heart rate	Variations of heart rate in beats per minute	6 hours after starting APRV
Secondary	Changes in catecholamine doses	Variations of catecholamine doses in milligrams per hours	6 hours after starting APRV
Secondary	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
Secondary	Variations of minute ventilation	Minute ventilation in liters per minute	6 hours after starting APRV
Secondary	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
Secondary	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