NCT03463798

Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 125 (actual)
• Sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Diaphragmatic Paralysis
• Healthy Volunteers

Interventions

Type	Name	Description
DEVICE	Sonar	Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly
DEVICE	Structured light plethysmography (SLP)	Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly

Timeline

• Start date: 2018-06-11
• Primary completion: 2021-09-21
• Completion: 2021-09-21
• First posted: 2018-03-13
• Last updated: 2023-09-14

Locations

1 site across 1 country: France