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临床试验/NCT05542069
NCT05542069尚未招募不适用

Measurement of the Diaphragm Loading During the Training With a Inspiratory Muscle Trainer Device

Clínica Basilea1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2022年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10
试验地点
1
主要终点
Diaphragm intervention during a certain percentage of resistive load with a IMT device

研究概览

简要总结

It is well known that the the training with the IMT device increases the Maximal Inspiratory Pressure. Nonetheless, there are doubts about which muscles are involved during this training. The aim of this study is to determine the diaphragm loading of healthy subjects during the training with a IMT device from a low . Therefore, each subject will be monitored using esophageal and gastric manometry.

详细描述

This study has a quasi-experimental design. We will recruit ten healthy adult volunteers without anticoagulation or esophageal lesions, after signing a consent form.

After checking the appropriate correct position of each catheter, each subject will use the IMT device throughout different randomized loads (percentages of the maximal inspiratory pressure, counting by tens from 10% to 100%). FluxMed® GrT MBMed respiratory mechanic monitor will be used. Each percentage of resistive load will be maintained for 5 inspirations. Meanwhile, an operator will register the esophageal pressure,the gastric pressure and the transdiaphragmatic pressure. Diaphragm collaboration in each percentage of resistive load will be determine by calculating the relation between the gastric pressure and the transdiaphragmatic pressure (∆Pgas/∆Pdi).

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

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

  • older than 18 years, healthy subjects -

排除标准

  • without anticoagulation, without esophageal lesions,without airway lesions and without spirometry alterations

结局指标

主要结局

Diaphragm intervention during a certain percentage of resistive load with a IMT device

时间窗: 1 year

The diaphragm intervention is determined by the relation of the gastric pressure and the transdiaphragmatic pressure

次要结局

未报告次要终点

研究者

发起方
Clínica Basilea
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dario Villalba

RT

Clínica Basilea

研究点 (1)

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