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Completed

NCT Number: NCT04386369

Evaluation of Airway Pressure Release Ventilation in COVID-19 ARDS

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Centre Hospitalier Régional Universitaire de Nancy

Nancy, 54500, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Airway pressure release ventilation

Other

Ventilator management strategy

Primary outcomes

  1. Proportion of patients improving PaO2/FiO2 ratio at 6 hours of APRV

    Time frame: 6 hours after starting APRV

    Increase of at least 20% of the PaO2/FiO2 ratio

Secondary outcomes

  1. Number of interventions on ventilator settings

    Time frame: 6 hours after starting APRV

    Number of interventions by the physician on APRV settings

  2. Change in mean blood pressure

    Time frame: 6 hours after starting APRV

    Variations of blood pressure in millimeters of mercury

  3. Change in heart rate

    Time frame: 6 hours after starting APRV

    Variations of heart rate in beats per minute

  4. Changes in catecholamine doses

    Time frame: 6 hours after starting APRV

    Variations of catecholamine doses in milligrams per hours

  5. Changes in static compliance at the end of 6 hours of APRV

    Time frame: 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)

  6. Variations of minute ventilation

    Time frame: 6 hours after starting APRV

    Minute ventilation in liters per minute

  7. Changes in static compliance 4 hours after stopping APRV

    Time frame: 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)

  8. Proportion of patients with a decrease of the PaO2/FiO2 ratio

    Time frame: 4 hours after stopping APRV

    Percentage of patients with a decrease of the PaO2/FiO2 ratio

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Official study title

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

Acronym: APRV-COVID19

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 13, 2020
Registry last updated
Sep 14, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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