Study of the Diaphragmatic Function by Transient Elastography (ELASTODIAPH) (ELASTODIAPH)

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Diagnostic test: Ultrasound

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • Pitié Salpétrière Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• healthy volunteer

Exclusion Criteria:

• chronic respiratory, neurologic or cardiac disease
• swallowing disorders
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subjects; Only one arm is considered	Diagnostic test: Ultrasound; Volitional and non volitional respiratory tasks; Other Names: Magnetic and electrical phrenic nerve stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transdiaphragmatic pressure	The transdiaphragmatic pressure is the sum of absolute values of gastric and oesophagal pressures	2 hours

Collaborators and Investigators

• Sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2017
• Primary Completion (Actual): October 27, 2017
• Study Completion (Actual): October 27, 2017

Study Registration Dates

• First Submitted: October 4, 2017
• First Submitted That Met QC Criteria: October 17, 2017
• First Posted (Actual): October 18, 2017

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 15, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: 2015-A00949-40

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No