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临床试验/NCT04386369
NCT04386369已完成不适用

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

Central Hospital, Nancy, France1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2020年4月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
17
试验地点
1
主要终点
Proportion of patients improving PaO2/FiO2 ratio at 6 hours of APRV

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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)

结局指标

主要结局

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

时间窗: 6 hours after starting APRV

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

次要结局

  • Variations of minute ventilation(6 hours after starting APRV)
  • 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)
  • Changes in static compliance 4 hours after stopping APRV(4 hours after starting APRV)
  • Proportion of patients with a decrease of the PaO2/FiO2 ratio(4 hours after stopping APRV)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

研究点 (1)

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