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临床试验/NCT00419458
NCT00419458已完成1 期

Respiratory Muscle Training in Ventilator Dependent Patients

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)2 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2004年2月1日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
150
试验地点
2
主要终点
ventilator dependent status

研究概览

简要总结

The purpose of this study is to determine if inspiratory muscle strength training will increase the proportion of ventilator dependent patients weaned versus Sham treated patients.

详细描述

The inspiratory muscle strength training consists of 4 sets of 6-10 breaths through a threshold inspiratory muscle strength training device, 5 days per week. The inspiratory muscle training is conducted at the highest pressure setting tolerated by the patients. The Sham groups uses an inspiratory muscle trainer that does not increase inspiratory muscle strength. Both the treated and Sham groups participate in progressively lengthening periods of breathing without ventilator as tolerated. Patients are considered weaned when they can breathe for 72 consecutive hours without any ventilator support.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
主要目的
Treatment
盲法
Single

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Failure to wean patients in the medial, surgical and intermediate respiratory care units at Shands Hospital
  • medically stable
  • able to initiate spontaneous breaths
  • able to provide informed consent
  • able to follow simple instructions

排除标准

  • life expectancy < 12 months due to malignancy
  • damaged phrenic nerves
  • neuromuscular diseases
  • heart or lung transplant

结局指标

主要结局

ventilator dependent status

次要结局

  • breathing patterns during failed and passed unsupported breathing trials
  • maximal inspiratory pressure

研究者

发起方
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
申办方类型
Nih

研究点 (2)

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