Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction

Completed

• Conditions: Diaphragmatic Paralysis; Healthy Volunteers
• Interventions: Device: Sonar; Device: Structured light plethysmography (SLP)

• Registration Number: NCT03463798
• Lead Sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Brief 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.

Study Timeline

• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-12
• Study First Posted: 2018-03-13
• Study Start: 2018-06-11
• Primary Completion: 2021-09-21
• Study Completion: 2021-09-21
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-13
• Last Update Posted: 2023-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy volunteers	Sonar	Subjects without any medical condition
Healthy volunteers	Structured light plethysmography (SLP)	Subjects without any medical condition
Patients	Sonar	Patients with a suspicion of diaphragmatic dysfunction
Patients	Structured light plethysmography (SLP)	Patients with a suspicion of diaphragmatic dysfunction

Primary Outcome Measures

Name	Time	Method
amplitude of displacement of thoraco-abdominal compartments	10 minutes	asymmetry of displacement of thoraco-abdominal compartments during tidal breathing and respiratory manoeuvres

Secondary Outcome Measures

Name	Time	Method
displacement speed of thoraco-abdominal compartments	10 minutes	asynchrony of displacement of thoraco-abdominal compartments during tidal breathing and respiratory manoeuvres measurement

Trial Locations

Locations (1)

INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière; 🇫🇷 Paris, France