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Clinical Trials/NCT05542069
NCT05542069Not yet recruitingNot Applicable

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

Clínica Basilea1 site in 1 country10 target enrollmentStarted: November 1, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
10
Locations
1
Primary Endpoint
Diaphragm intervention during a certain percentage of resistive load with a IMT device

Study Overview

Brief Summary

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.

Detailed Description

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).

Study Design

Study Type
Observational
Observational Model
Other
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • older than 18 years, healthy subjects -

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 1 year

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

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Clínica Basilea
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dario Villalba

RT

Clínica Basilea

Study Sites (1)

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