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临床试验/NCT04664322
NCT04664322已完成不适用

High-flow Oxygen Therapy Versus Non-invasive Ventilation: a Randomised Physiological Cross-over Study of Alveolar Recruitment in Acute Respiratory Failure

University Hospital, Rouen1 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2016年2月22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
16
试验地点
1
主要终点
global EELI

研究概览

简要总结

This physiological study showed an increase in regional ventilation with NIV but no difference in alveolar recruitment as compared to HFNC in patients with hypoxemic ARF. Although NIV provided better oxygenation than HFNC, the effect on lung volumes could explain the potentially deleterious effect of NIV in hypoxemic ARF, reinforcing the recently developed concept of patient self-inflicted lung injury.

详细描述

Background: High-flow nasal cannula (HFNC) oxygen therapy has recently shown clinical benefits in hypoxemic acute respiratory failure (ARF) patients, while the interest of non-invasive ventilation (NIV) remains debated. The primary endpoint was to compare alveolar recruitment using global end-expiratory electrical lung impedance (EELI) between HFNC and NIV. Secondary endpoints compared regional EELI, lung volumes (global and regional tidal volume variation (TV)), respiratory parameters, hemodynamic tolerance, dyspnea and patient comfort between HFNC and NIV, relative to face mask (FM).

研究设计

研究类型
Observational
观察模型
Case Crossover
时间视角
Prospective

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

  • Adult patients referred in ICU
  • with hypoxemic acute respiratory failure due to a community acquired pneumonia confirmed by chest X ray,
  • with PaO2 < 60mmHg in ambient air, without hypercapnia (PaCO2 < 45 mmHg),
  • requiring more than 6L/min of O2 on admission with high concentration FM, and justifying HFNC or NIV for the attending ICU physician

排除标准

  • cardiogenic pulmonary oedema,
  • moderate to severe underlying respiratory disease including COPD (chronic obstructive pulmonary disease)
  • contraindication to or failure of previous NIV or HFNC with the need for immediate invasive ventilation
  • pregnant or breast-feeding women
  • carrier of an implantable defibrillator or pacemaker
  • body mass index (BMI)>50 kg/m2
  • with cutaneous lesion next to the positioning zone of the Pulmovista® (Dräger, Lübeck, Germany) belt

结局指标

主要结局

global EELI

时间窗: after 5 minutes of stable breathing with the oxygenation technic

measurement of global end respiratory lung impedance with non invasive ventilation vs with high flow nasal canulae oxygen therapy, standard unit

次要结局

  • ROI EELI(after 5 minutes of stable breathing with the oxygenation technic)
  • global TV(after 5 minutes of stable breathing with the oxygenation technic)
  • ROI TV(after 5 minutes of stable breathing with the oxygenation technic)

研究者

发起方
University Hospital, Rouen
申办方类型
Other
责任方
Sponsor

研究点 (1)

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