Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction

NCT ID: NCT03463798

Last Updated: 2023-09-14

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

Total Enrollment

125 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-11

Study Completion Date

2021-09-21

Brief Summary

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this study aim to evaluate wether new, non-invasive and non-contact devices such as Structured Light Plethysmography (SLP) and Sonar would be able to accurately detect and quantify diaphragm dysfunction (mono-or-bilateral) by assessing the asymmetric chest wall motion generated during spontaneous breathing as compared with a classic, standard and invasive technique.

Detailed Description

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The measurements of chest and abdominal wall movements during quiet tidal breathing will be performed simultaneously using SLP and Sonar devices.

Subjects will be asked to sit down on a chair with their neck in a neutral position and their back as straight as possible. The SLP and the Sonar will be lined up to project the grid of light and the ultrasonic wave sonar over the participant's chest and abdomen. Data will be collected during 5 minutes of tidal breathing. The same procedure will be repeated while having the patient lying down in supine position on the same chair for 5 additional minutes. During both sessions (sitting and supine), patients will be asked to perform a gentle inspiratory capacity (IC) maneuver to better appreciate the thoraco-abdominal asymmetry and distortion.

Conditions

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Diaphragmatic Paralysis Healthy Volunteers

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients with a suspicion of diaphragmatic dysfunction

Sonar

Intervention Type DEVICE

Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly

Structured light plethysmography (SLP)

Intervention Type DEVICE

Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly

Healthy volunteers

Subjects without any medical condition

Sonar

Intervention Type DEVICE

Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly

Structured light plethysmography (SLP)

Intervention Type DEVICE

Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly

Interventions

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Sonar

Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly

Intervention Type DEVICE

Structured light plethysmography (SLP)

Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* no respiratory disease
* no neurologic disease
* no thoracic deformation


* patients with a suspicion of diaphragmatic dysfunction

Exclusion Criteria

* respiratory disease
* neurologic disease
* thoracic deformation

FOR PATIENTS


* pregnant women
* contraindications to standard procedure requiring transdiaphragmatic measurement
Minimum Eligible Age

18 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

Principal Investigators

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Pierantonio LAVENEZIANA, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

UMRS_1158

Locations

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INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière

Paris, , France

Site Status

Countries

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France

Other Identifiers

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2017-A03665-48

Identifier Type: -

Identifier Source: org_study_id

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