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

September 13, 2022 updated by: Dario Villalba, Clínica Basilea

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

10

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

healthy adult volunteers

Description

Inclusion Criteria: older than 18 years, healthy subjects -

Exclusion Criteria: without anticoagulation, without esophageal lesions,without airway lesions and without spirometry alterations

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clínica Basilea

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

November 1, 2022

Primary Completion (Anticipated)

September 30, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

September 13, 2022

First Submitted That Met QC Criteria

September 13, 2022

First Posted (Actual)

September 15, 2022

Study Record Updates

Last Update Posted (Actual)

September 15, 2022

Last Update Submitted That Met QC Criteria

September 13, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ABC123 (Mansoura university)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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