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临床试验/NCT03928535
NCT03928535Unknown不适用

Effect of Postextubation High-Flow Nasal Cannula vs Noninvasive Ventilation on Reintubation and Postextubation Respiratory Failure in Patients With Hypercapnic COPD,a Randomized Controlled Trial

Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2016年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
1
主要终点
Rate of reintubation

研究概览

简要总结

To test if high-flow conditioned oxygen therapy is noninferior to NIV for preventing postextubation respiratory failure and reintubation in patients with hypercapnic COPD, investigators plan to conduct the participants level, 1:1 randomized trial at the respiratory ICU. Participants were randomized to undergo either high-flow conditioned oxygen therapy or noninvasive mechanical ventilation after extubation. Primary outcomes were reintubation and postextubation respiratory failure within 72 hours. Secondary outcomes included length of RICU stay after extubation and mortality; partial pressure of arterial carbon dioxide.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Clinical diagnosis of AECOPD
  • Extubation must be performed after 48 hours of invasive ventilation
  • Must be treated sequentially with HFNC or NIV after extubation
  • PaCO2≥50mmHg when extubation
  • Positive End Expiratory Pressure (PEEP) ≤8cmH2O (1cmH2O=0.098 kPa) when extubation

排除标准

  • Do-not-intubate
  • Tracheostomies
  • Accidental extubation
  • Self-extubation

研究组 & 干预措施

High-Flow Nasal Cannula

Other

High-flow oxygen was applied immediately after extubation through specific nasal cannula.

干预措施: High-FlowNasal Cannula (Device)

Noninvasive Ventilation

Other

Noninvasive Ventilation was applied immediately after extubation.

干预措施: Noninvasive Ventilation (Device)

结局指标

主要结局

Rate of reintubation

时间窗: Within 72 hours after extubation

The proportion of patients requiring reintubation within 72 hours after extubation

次要结局

  • Mortality(Within 28 days after extubation)
  • RICU length of stay after extubation(From date of extubation until the date of discharging from the RICU up to 28 days)
  • Partial pressure of arterial carbon dioxide(Within 24 hours before extubation and within 72 hours after extubation)

研究者

发起方
Xiangya Hospital of Central South University
申办方类型
Other
责任方
Sponsor

研究点 (1)

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