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临床试验/NCT00355732
NCT00355732已完成4 期

Chronic Obstructive Pulmonary Disease and Weaning From Mechanical Ventilation in Difficult to Wean Patients; Randomized Prospective Study

Dr. Josip Benčević General Hospital4 个研究点 分布在 1 个国家开始时间: 2006年7月25日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
试验地点
4

研究概览

简要总结

To evaluate and compare two methods of weaning from mechanical ventilation in patients with chronic obstructive pulmonary disease (COPD) where the extubation failed.

详细描述

A prospective, randomized trial was performed in a multidisciplinary Intensive Care Unit (ICU) for the duration of 2 years. A total of 136 COPD patients who required mechanical ventilation longer than 24 h fulfilled the inclusion criteria and they present the research sample. After fulfilling the criteria for weaning, patients were randomized to a 2-h spontaneous breathing trial with either T-tube or pressure support ventilation (PSV). The patients with successful 2-h trial were extubated and were excluded from further research. Patients with 2-h trial failure were defined as difficult to wean, they had mechanical ventilation reinstated and the same weaning procedure was repeated after 24 h, if the patient again fulfilled the weaning criteria. In these patients, two methods of weaning were compared according to the patients clinical characteristics, objective parameters and procedure outcome.

31 (47%) patient with T-tube and 32 (46%) patients with PSV had 2-h trial failure. Of those patients, successful extubation was in 17 (56%) patients with T-tube and in 23 (72%) with PSV (P <0.001), whereas extubation failure was in 14 (44%) patients with T-tube and in 9 (28%) patients with PSV (P <0.001). Mechanical ventilation duration was 186.7 h with T-tube and 163.2 h with PSV (P <0.001), time spent in ICU was 240.7 h with T-tube and 210.2 h with PSV (P <0.001).

In patients with COPD who failed the 2-h spontaneous breathing trial, based on parameters of procedure outcome, high advantage of PSV method was confirmed.

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

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

  • exacerbation of dyspnea <2 weeks
  • signs of respiratory muscle dysfunction

排除标准

  • non COPD patients
  • age <18 years
  • tracheotomy
  • MV duration shorter than 24h
  • use of MV on admission to the ICU or transfer to some other ICU for treatment continuation
  • patients who died or weaning from MV was discontinued because of another associated disorder
  • central nerve system disorders unrelated to hypercapnic encephalopathy or hypoxemia
  • cardiac arrest within 5 days
  • patients scheduled for organ donation

研究者

发起方
Dr. Josip Benčević General Hospital
申办方类型
Other

研究点 (4)

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