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Study of the Diaphragmatic Function by Transient Elastography (ELASTODIAPH)

NCT ID: NCT03313141

Last Updated: 2017-12-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

14 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-09

Study Completion Date

2017-10-27

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

To compare diaphragm elastrography provided by ultrasound to diaphragm function indices provided by magnetic/electrical phrenic nerves stimulation
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Subjects

Only one arm is considered

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DIAGNOSTIC_TEST

Volitional and non volitional respiratory tasks

Interventions

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Ultrasound

Volitional and non volitional respiratory tasks

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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Magnetic and electrical phrenic nerve stimulation

Eligibility Criteria

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Inclusion Criteria

* healthy volunteer

Exclusion Criteria

* chronic respiratory, neurologic or cardiac disease
* swallowing disorders
* pregnancy
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Pitie Salpêtrière Hospital

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2015-A00949-40

Identifier Type: -

Identifier Source: org_study_id