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临床试验/NCT04036175
NCT04036175Unknown不适用

Comparison of Patient Work of Breathing and Tidal Volumes With High-flow Nasal Cannula Oxygen Therapy and Non-invasive Ventilation After Extubation in the ICU: a Prospective, Randomized, Controlled Study

Poitiers University Hospital4 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2018年3月6日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
25
试验地点
4
主要终点
Patient respiratory effort and tidal volume (Vt)

研究概览

简要总结

This study is aimed at evaluating patient work of breathing and tidal volumes with three methods of oxygenation: standard oxygen, high-flow oxygen therapy and non-invasive ventilation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

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

  • Minimum age: 18 years
  • planned extubation decided by the physician in charge of the patient after success of weaning trial
  • patients at high risk of reintubation according to the following criteria: patient older than 65 years, or those having any underlying chronic cardiac or lung disease
  • Hypoxemia defined by PaO2/FiO2 < 300 mmHg under mechanical ventilation before extubation

排除标准

  • Duration of mechanical ventilation prior to extubation < 24h
  • Contraindication to NIV
  • Contraindication to nasogastric tube
  • Do-not-reintubated order at time of extubation
  • People under legal protection
  • Opposition to participate

研究组 & 干预措施

Group 1

Other

Standard oxygen - High-Flow Nasal Oxygen - Non-invasive ventilation - Standard Oxygen (20 minutes for each condition)

干预措施: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen (Device)

Group 2

Other

Standard oxygen - Non-invasive ventilation - High-Flow Nasal Oxygen - Standard Oxygen (20 minutes for each condition)

干预措施: High-Flow Nasal Oxygen / Non-invasive ventilation / Standard oxygen (Device)

结局指标

主要结局

Patient respiratory effort and tidal volume (Vt)

时间窗: 1h20

Swing of oesophageal pressure and pressure-Time product measured by a nasogastric pressure sensor tidal Volume estimated by electric impedance tomography

次要结局

  • Hemodynamic parameters("Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min")
  • Comfort evaluation("Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min")
  • Respiratory parameters("Time 0","Time 20 min", "Time 40 min", "Time 60 min", "Time 120 min")

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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