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临床试验/NCT02003053
NCT02003053已完成不适用

A Randomized, Controlled Trial of Inspiratory Muscle Training (IMT)in the ICU and CCU

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2013年4月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
7
试验地点
2
主要终点
Safety and Feasibility of Inspiratory Muscle Training

研究概览

简要总结

Inspiratory muscle training (IMT) is an intervention used with success in the outpatient setting within the COPD population. Use of IMT is also theoretically possible during mechanical ventilation. This study will will assess the feasibility and safety of the study of IMT in the patient population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Mechanically ventilated patients.
  • Must have passed spontaneuos brething trial screening but failed the trial itself.
  • Potential subject must be able to perform atleast 5 minutes of spontaneous breathing trial.

排除标准

  • Known neuromuscular disease
  • Unstable cardiac ischemia
  • Tracheostomized patients

研究组 & 干预措施

IMT

Experimental

In the IMT group, inspiratory muscle training will start with 30% of MIP, for five minutes twice a day with increments of 10 % (absolute) everyday. Supplemental oxygen will be given as needed. The exercise will be done seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.

干预措施: Inspiratory Muscle Trainer (Device)

Sham

Sham Comparator

In the SHAM group, sham device will be used to train subjects 5 minutes twice a day, seven days a week until patient achieves liberation from mechanical ventilation or ICU/CCU discharge.

干预措施: Inspiratory Muscle Trainer (Device)

结局指标

主要结局

Safety and Feasibility of Inspiratory Muscle Training

时间窗: Baseline and until participant is extubated or discharged from the critical care unit (up to 1 month post-baseline)

The number of patients tolerating Inspiratory Muscle Training or Sham.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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