Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction

Healthy Volunteers Clinical Trial

— DYSDIA  

Official title:

Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03463798
• Other study ID #: 2017-A03665-48
• Status: Completed
• 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
• 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

Related Conditions & MeSH terms

• Diaphragmatic Paralysis
• Healthy Volunteers
• Paralysis
• Respiratory Paralysis

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