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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03463798
Other study ID # 2017-A03665-48
Secondary ID
Status Completed
Phase
First received
Last updated
Start date June 11, 2018
Est. completion date September 21, 2021

Study information

Verified date September 2023
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 Observational

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 125
Est. completion date September 21, 2021
Est. primary completion date September 21, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility FOR HEALTHY VOLUNTEERS Inclusion Criteria: - no respiratory disease - no neurologic disease - no thoracic deformation Exclusion criteria - respiratory disease - neurologic disease - thoracic deformation FOR PATIENTS Inclusion Criteria: - patients with a suspicion of diaphragmatic dysfunction Exclusion Criteria: - pregnant women - contraindications to standard procedure requiring transdiaphragmatic measurement

Study Design


Intervention

Device:
Sonar
Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly
Structured light plethysmography (SLP)
Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly

Locations

Country Name City State
France INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière 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 amplitude of displacement of thoraco-abdominal compartments asymmetry of displacement of thoraco-abdominal compartments during tidal breathing and respiratory manoeuvres 10 minutes
Secondary displacement speed of thoraco-abdominal compartments asynchrony of displacement of thoraco-abdominal compartments during tidal breathing and respiratory manoeuvres measurement 10 minutes
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