Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction (DYSDIA)

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

Status: Completed

Conditions: Healthy Volunteers; Diaphragmatic Paralysis

Treatments: Device: Structured light plethysmography (SLP); Device: Sonar

Study type: Observational

Funder types: Other

Identifiers

NCT03463798

2017-A03665-48

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

125 participants in 2 patient groups

Patients

Description:

Patients with a suspicion of diaphragmatic dysfunction

Treatment:

Device: Structured light plethysmography (SLP)

Device: Sonar

Healthy volunteers

Description:

Subjects without any medical condition

Treatment:

Device: Structured light plethysmography (SLP)

Device: Sonar