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NCT03313141 Clinical Trial

Study of the Diaphragmatic Function by Transient Elastography (ELASTODIAPH)

Healthy Clinical Trial

— ELASTODIAPH  

Official title:
Study of the Diaphragmatic Function by Transient Elastography : Comparison With Mechanical and Electrophysiological Variables

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03313141
Other study ID # 2015-A00949-40
Secondary ID
Status Completed
Phase N/A
First received October 4, 2017
Last updated December 15, 2017
Start date October 9, 2017
Est. completion date October 27, 2017

Study information
Verified date December 2017
Source Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study of diaphragmatic function is usually measured by the pressures and volumes generated by contraction of the diaphragm, which is often difficult (cumbersome technique, difficulty to obtain a perfect cooperation of the subjects, and difficulty to specifically analyze the diaphragm compared to other accessory respiratory muscle groups). In this study, the investigators aimed at analysing diaphragmatic function by measuring the shortening, stiffness, strain and thickening of the diaphragm by ultrasound.

Recruitment information / eligibility
Status Completed
Enrollment 14
Est. completion date October 27, 2017
Est. primary completion date October 27, 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

- healthy volunteer

Exclusion Criteria:

- chronic respiratory, neurologic or cardiac disease

- swallowing disorders

- pregnancy

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Ultrasound
Volitional and non volitional respiratory tasks

Locations
Country Name City State
France Pitie Salpêtrière Hospital Paris

Sponsors (1)
Lead Sponsor Collaborator
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Transdiaphragmatic pressure The transdiaphragmatic pressure is the sum of absolute values of gastric and oesophagal pressures 2 hours
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