Measurement of the Diaphragm Loading During the Training With a IMT Device

Not yet recruiting

• Conditions: Sports Physical Therapy

• Registration Number: NCT05542069
• Lead Sponsor: Clínica Basilea

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 Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-13
• Study First Submitted QC: 2022-09-13
• Last Update Submitted: 2022-09-13
• Study First Posted: 2022-09-15
• Last Update Posted: 2022-09-15
• Study Start: 2022-11-01
• Primary Completion: 2023-09-30
• Study Completion: 2023-12-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

older than 18 years, healthy subjects -

Exclusion Criteria

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diaphragm intervention during a certain percentage of resistive load with a IMT device	1 year	The diaphragm intervention is determined by the relation of the gastric pressure and the transdiaphragmatic pressure

Trial Locations

Locations (1)

Clinica Basilea; 🇦🇷 Buenos Aires, Argentina