Evaluation of Airway Pressure Release Ventilation in COVID-19 ARDS

NCT04386369 | Completed

• 1 other identifier: 2020PI076
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

ARDS; COVID19

Keywords

Airway Pressure Release Ventilation; Intensive Care Unit; SARS-CoV-2; APRV; Acute respiratory failure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Number of interventions on ventilator settings

  6 hours after starting APRV

• Change in mean blood pressure

  6 hours after starting APRV

• Change in heart rate

  6 hours after starting APRV

• Changes in catecholamine doses

  6 hours after starting APRV

• Changes in static compliance at the end of 6 hours of APRV

  6 hours after starting APRV

Study Arms (1)

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

Interventions

Airway pressure release ventilation OTHER

Ventilator management strategy

Airway Pressure Release Ventilation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Study Sites (1)

Centre Hospitalier Régional Universitaire de Nancy

Nancy, 54500, France

Location

Related Publications (2)

• 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.

  PMID: 28936695 BACKGROUND

• 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.

  PMID: 32265734 BACKGROUND

MeSH Terms

Conditions

COVID-19

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Study Officials

• Matthieu Koszutski, MD

  CHRU de NANCY, Médecine Intensive et Réanimation Brabois

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2020
• First Posted: May 13, 2020
• Study Start: April 15, 2020
• Primary Completion: June 1, 2020
• Study Completion: June 1, 2020
• Last Updated: September 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)