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临床试验/NCT02214368
NCT02214368已完成不适用

The Efficacy and Safety of Noninvasive Ventilation Bundle in Postoperative Respiratory Failure

West China Hospital1 个研究点 分布在 1 个国家目标入组 158 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
158
试验地点
1
主要终点
the need of endotracheal intubation

研究概览

简要总结

The investigators assessed the efficacy and safety of this noninvasive Ventilation (NIV) bundle strategy compared with a conventional treatment in postoperative patients with ARF.

详细描述

This is a randomized, prospective, open-label study. Postoperative patients with ARF included in the study were randomly assigned to intervention group or conventional treatment group. In the intervention group, NIV was early used for treatment of postoperative respiratory failure, if patients were inability to spontaneously clear airways from excessive secretions during NIV, fiberoptic bronchoscopy (FBO) was used for suction of secretions , if patients showed intolerance or inadequate patient cooperation during the NIV session, they were sedated (Ramsay scale 2-3) by a continuous perfusion of propofol during the NIV session.

Patients assigned to the control group received supplemental oxygen, Respiratory therapists delivered this intervention using conventional masks or venturi oxygen, and adjusted FiO2 to achieve arterial O2 saturation of more than 92%. The application of noninvasive ventilation was considered, if patients failed the supplemental oxygen and met at least two of the following criteria:(1) severe respiratory distress with dyspnoea, respiratory rate>30breaths/min, and clinical signs suggestive of respiratory-muscle fatigue or increased respiratory effort (use of accessory respiratory muscles or paradoxical abdominal breathing, or intercostal indrawing), (2) respiratory acidosis (arterial pH of 7.35 or less with PaCO2 of 45 mm Hg or more) ;(3) arterial O2 saturation by pulse oximetry less than 90% or PaO2 less than 60 mm Hg at an FiO2> 0.5 or breathing at least 10 l/min oxygen.

All the patients were continuous monitored of vital signs.whereas arterial blood gases were analyzed before NIV and 1h after NIV, before and after FBO, and once a day and in the case of any change either in the ventilatory settings or in the FIO2; duration of noninvasive ventilation, the rate and cause of endotracheal intubation, ICU and hospital mortality and length of stay in the ICU and in hospital, study procedure related complications.

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
None

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Postoperative patients with acute respiratory failure (ARF) were included in the study,who had to meet one of the following criteria
  • Respiratory acidosis (arterial pH of 7.35 or less with PaCO2 of 45 mm Hg or more)
  • Partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ratio less than 250
  • Dyspnoea with respiratory rate > 25 breaths/min or use of accessory respiratory muscles or paradoxical abdominal breathing

排除标准

  • Cardiac or respiratory arrest; loss of consciousness
  • Facial trauma or surgery or deformity sufficient to preclude mask fitting
  • Active upper gastrointestinal bleeding
  • Haemodynamic instability or unstable cardiac arrhythmia
  • Multiple organ failure

研究组 & 干预措施

NIV bundle group

Experimental

early use of NIV, and combination fiberoptic bronchoscopy and sedation

干预措施: Early application of NIV (Other)

NIV bundle group

Experimental

early use of NIV, and combination fiberoptic bronchoscopy and sedation

干预措施: Fiberoptic bronchoscopy (Device)

NIV bundle group

Experimental

early use of NIV, and combination fiberoptic bronchoscopy and sedation

干预措施: Propofol (Drug)

Conventional treatment group

Other

standard supplemental oxygen, and conventional application of noninvasive ventilation.

干预措施: Conventional application of NIV (Other)

结局指标

主要结局

the need of endotracheal intubation

时间窗: 7 days

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Zhou Yongfang

Master of medicine

West China Hospital

研究点 (1)

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