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临床试验/NCT06375538
NCT06375538招募中不适用

Ultrasound Evaluations of Diaphragm and Intercostal Muscle to Predict the Failure of High-Flow Nasal Cannula Therapy

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2022年10月21日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Ultrasound evaluation of diaphragm

研究概览

简要总结

The study aims to predict the failure of High-flow Nasal Cannula oxygenation therapy by ultrasound evaluation of diaphragm and intercostal muscle contraction during the first 24 hours.

研究设计

研究类型
Observational
观察模型
Cohort
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

  • more than 18 years old
  • needing High-flow Nasal Cannula oxygenation therapy

排除标准

  • received mechanical ventilation, including invasive or noninvasive ventilation within one month prior to enrollment
  • history of neuromuscular disorders (e.g., myasthenia gravis, Guillain-Barre syndrome);
  • immediate endotracheal intubation is required (life-threatening hypoxemia)
  • extensive damage to the thoracic skin (e.g., burns) unable to undergo ultrasonography
  • pregnancy
  • attending physician deemed it inappropriate to participate in the trial.

结局指标

主要结局

Ultrasound evaluation of diaphragm

时间窗: Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.

Thickness of the diaphragmatic muscle and the diaphragm thickening fraction (DTF) by ultrasound evaluation

The patient's condition deteriorated and required noninvasive or intubated invasive mechanical ventilation.

时间窗: up to 30 days after High-flow Nasal Cannula (HFNC)oxygenation therapy.

Failing or not failing HFNC, the rate of needing noninvasive or intubated invasive mechanical ventilation.

Ultrasound evaluation of intercostal muscle movement index

时间窗: Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.

the parasternal intercostal muscles thickening fraction by ultrasound evaluation

次要结局

  • ICU stay(up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.)
  • all cause mortality(up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.)
  • VT(Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.)
  • duration on HFNC(up to one month)
  • Hospital stay(up to one month after High-flow Nasal Cannula (HFNC)oxygenation therapy.)
  • respiratory rate(Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.)
  • Oxygen saturation(Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.)
  • oxygen concentration(Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.)
  • flow velocity of HFNC(Six times a day by the 0,2,6,12,18,24 hours following initiation of High-flow Nasal Cannula (HFNC)oxygenation treatment.)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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