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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers; Diaphragmatic Paralysis
• Intervention / Treatment: Device: Sonar; Device: Structured light plethysmography (SLP)

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 Type: Observational
• Enrollment (Actual): 125

Contacts and Locations

Study Locations

• France
  • Paris, France, 75013
    • INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Patients with a suspicion of diaphragmatic dysfunction and healthy volunteers without any medical condition.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients; Patients with a suspicion of diaphragmatic dysfunction	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
Healthy volunteers; Subjects without any medical condition	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amplitude of displacement of thoraco-abdominal compartments	asymmetry of displacement of thoraco-abdominal compartments during tidal breathing and respiratory manoeuvres	10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
displacement speed of thoraco-abdominal compartments	asynchrony of displacement of thoraco-abdominal compartments during tidal breathing and respiratory manoeuvres measurement	10 minutes

Collaborators and Investigators

• Sponsor: Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
• Investigators: Principal Investigator: Pierantonio LAVENEZIANA, MD, PhD, UMRS_1158

Study record dates

Study Major Dates

• Study Start (Actual): June 11, 2018
• Primary Completion (Actual): September 21, 2021
• Study Completion (Actual): September 21, 2021

Study Registration Dates

• First Submitted: March 7, 2018
• First Submitted That Met QC Criteria: March 12, 2018
• First Posted (Actual): March 13, 2018

Study Record Updates

• Last Update Posted (Actual): September 14, 2023
• Last Update Submitted That Met QC Criteria: September 13, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: structured light plethysmography; sonar; transdiaphragmatic pressure
• Additional Relevant MeSH Terms: Nervous System Diseases; Respiratory Tract Diseases; Respiration Disorders; Neurologic Manifestations; Respiratory Insufficiency; Paralysis; Respiratory Paralysis
• Other Study ID Numbers: 2017-A03665-48

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No