Measurement of the Diaphragm Loading During the Training With a IMT Device
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Threshold IMT (Inspiratory muscle trainer) by Philips.
- Who it may be relevant to
- Registry conditions: Sports Physical Therapy. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Argentina
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Measurement of the Diaphragm Loading During the Training With a Inspiratory Muscle Trainer Device
Overview
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. The investigators 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).
Interventions
- Device Threshold IMT (Inspiratory muscle trainer) by Philips
Apply a resistive load with the IMT device according the maximal inspiratory pressure of each subject.
Primary outcome measures
- Diaphragm intervention during a certain percentage of resistive load with a IMT device [Time frame: 1 year]
Eligibility criteria
Inclusion criteria
- older than 18 years
- healthy subjects
Exclusion criteria
- without anticoagulation
- without esophageal lesions
- without airway lesions
- without spirometry alterations
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Other
Study locations
Argentina · 1 center
- Clinica Basilea — Buenos Aires
Identifiers
NCT: NCT05542069 · Basilea00000000000000001