跳至主要内容
临床试验/NCT01151501
NCT01151501撤回不适用

Noninvasive Positive Pressure Ventilation for Early Extubation of Acute Hypoxemic Respiratory Failure

Beijing Chao Yang Hospital1 个研究点 分布在 1 个国家开始时间: 2010年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Duration of invasive positive pressure ventilation

研究概览

简要总结

Acute hypoxaemic respiratory failure (AHRF) refers to pathological states in which arterial blood oxygenation is severely impaired,and which need invasive positive pressure ventilation (IPPV) as respiratory support technique in most cases.However,IPPV carries well-known risks of complications such as ventilator induced lung injury (VILI) or ventilator associated pneumonia (VAP),and the incidence of which is increased as the prolongation of IPPV so as to lead to higher mortality rate. Consequently,early extubation is extraordinarily necessary.

More recently, NPPV has shown to shorten the duration of IPPV,reduce the mortality and morbidity rates in patients with chronic obstructive pulmonary disease (COPD). Despite this evidence, the efficacy of NPPV in patients with AHRF has not been evidenced. However,NPPV has been shown to provide adequate ventilation and oxygenation,and reduce inspiratory muscle effort,neuromuscular drive,and dyspnea scores. Moreover,to some patints,NPPV is similar with IPPV in providing oxygenation.

The duration of weaning is from the first day a patient met standard criteria for weaning readiness to the time of successful extubation (lasting at least 48 h),which represents 40-50% of the total duration of IPPV.As a result,duration of IPPV would be shortened if that of weaning was shortened.

The investigators hypothesized that in mechanical ventilated patients with AHRF who met standard criteria for weaning readiness and suffer failure of spontaneous breathing trial, use of NPPV for early extubation, providing adequate ventilation and oxygenation, would shorten the duration of IPPV as the primary end-point variable, thereby reduce the incidence of complication and mortality rates. Accordingly, the investigators conducted a prospective,randomized clinical trial to assess the efficacy of this strategy compared with the conventional-weaning approach.

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 (Participant)

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

  • Orotracheal intubation
  • Arterial oxygen tension (PaO2)<60mmHg(venturi mask,FiO2=0.5),and arterial carbon dioxide tension(PaCO2)≤45mmHg;
  • Meeting standard criteria for weaning readiness
  • Suffering failure of spontaneous breathing trial.

排除标准

  • Duration of invasive positive pressure ventilation<48h
  • Tracheotomy
  • Percentage of cuff leak volume in tidal volume<15.5%
  • Unable to spontaneously clear secretions from their airway
  • Recent oral,nasal,facial or cranial trauma or surgery
  • Recent gastric or esophageal surgery
  • Active upper gastro-intestinal bleeding
  • Severe abdominal distension
  • Lack of co-operation
  • Chronic respiratory disease such as chronic obstructive pulmonary disease,asthma,interstitial lung disease,etc.

研究组 & 干预措施

noninvasive positive pressure ventilation

Experimental

干预措施: noninvasive positive pressure ventilation (Device)

结局指标

主要结局

Duration of invasive positive pressure ventilation

时间窗: two year

次要结局

  • Intensive care unit mortality(two years)
  • Incidence of ventilator associated pneumonia(two year)
  • Hospital mortality(two years)
  • 90-day survival after entry(two years)

研究者

发起方
Beijing Chao Yang Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Zujin Luo

MD

Beijing Chao Yang Hospital

研究点 (1)

Loading locations...

相似试验