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临床试验/NCT04507451
NCT04507451Unknown不适用

Inspiratory and Expiratory Muscle Training in Critically Ill Patients Weaned From Mechanical Ventilation

University of Liege1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
1
主要终点
change in inspiratory muscle strength

研究概览

简要总结

Respiratory muscle weakness is common after mechanical ventilation and occurs early. This can limit functional recovery. Respiratory muscle training is often neglected in clinical practice. Some data indicates that inspiratory muscle training increases inspiratory muscle strength and quality of life. The aim of the study is to assess the impact of combined inspiratory and expiratory muscle training on inspiratory muscle strength. The second aim is to assess the impact of this training program on expiratory muscle strength.

研究设计

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

盲法说明

patients are masked: they will all benefit from respiratory physiotherapy, with placebo or real muscle training investigator and care providers are unmasked, as they set the training parameters

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •patient from mechanical ventilation after at least 24 hours of support
  • •collaborative patient

排除标准

  • •confusion, mental disorder
  • •not french speaking
  • •pulmonary surgery in the past 12 months
  • •external ventricular drain
  • •previous pneumothorax or pneumothorax not drained
  • •rib fractures
  • •alveolar hemorrhage
  • •hemodynamic instability
  • •labial occlusion impossible (face burn, facial paralysis)
  • •patient refusal

研究组 & 干预措施

Trained group

Experimental

Patients will benefit from usual respiratory physiotherapy (secretion clearance treatment and recruitment maneuvers), and muscle training. This program will be delivered 5 days a week.

Inspiratory muscle training (IMT): using a threshold IMT device with mouthpiece, 5 sets of 6 breaths, intensity is prescribed at 60% of maximal inspiratory pressure for the first set, and then increased to the highest tolerable intensity to allow completion of the 6th breath Expiratory muscle training (EMT): using a bottle filled with water, starting at 5cm and then increased to 8 cm gradually, 5 sets of 6 breaths

Training program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge

干预措施: inspiratory and expiratory muscle training (Procedure)

Untrained group

Placebo Comparator

Patients will benefit from usual respiratory physiotherapy (secretion clearance treatment and recruitment maneuvers), and muscle exercises that are not planned to train muscles. This program will be delivered 5 days a week.

Inspiratory exercises: fractionated inspiration, 5 sets of 6 breaths Expiratory exercises: using a bottle filled with water (1 cm)

Exercises program starts after mechanical ventilation weaning, as soon as the patient is collaborative, and is continued until 1 month after ICU discharge

干预措施: inspiratory and expiratory exercises (Procedure)

结局指标

主要结局

change in inspiratory muscle strength

时间窗: 1 month after ICU discharge (compared to ICU discharge)

measurement of maximal inspiratory pressure

change in inspiratory muscle strength

时间窗: between 7 to 15 days after ICU discharge (compared to ICU discharge)

measurement of maximal inspiratory pressure

次要结局

  • change in expiratory muscle strength(1 month after ICU discharge (compared to ICU discharge))
  • respiratory infections(1 month after ICU discharge)
  • change in dyspnea perception(1 month after ICU discharge (compared to hospital discharge))
  • impact of dyspnea on physical activities(1 month after ICU discharge)
  • change in expiratory muscle strength(between 7 to 15 days after ICU discharge (compared to ICU discharge))
  • impact of dyspnea on physical activities(between 7 to 15 days after ICU discharge)

研究者

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

Rousseau

Head of clinic

University of Liege

研究点 (1)

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