DYSDIA: Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction

Sponsor

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

Overall Status

Recruiting

CT.gov ID

NCT03463798

Collaborator

(none)

180

Enrollment

Location

180

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Diaphragmatic Paralysis Healthy Volunteers	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 Design

Study Type:

Observational

Anticipated Enrollment :

180 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction

Actual Study Start Date :

Jun 11, 2018

Anticipated Primary Completion Date :

Jan 30, 2033

Anticipated Study Completion Date :

Jun 11, 2033

Arms and Interventions

Arm	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

Arm

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

Outcome Measures

Primary Outcome Measures

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

displacement speed of thoraco-abdominal compartments [10 minutes]
asynchrony of displacement of thoraco-abdominal compartments during tidal breathing and respiratory manoeuvres measurement

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière	Paris		France	75013

Sponsors and Collaborators

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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

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

ClinicalTrials.gov Identifier:

NCT03463798

Other Study ID Numbers:

2017-A03665-48

First Posted:

Mar 13, 2018

Last Update Posted:

Jul 23, 2021

Last Verified:

Jul 1, 2021

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

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

structured light plethysmography

sonar

transdiaphragmatic pressure

Additional relevant MeSH terms:

Respiratory Paralysis

Paralysis

Study Results

No Results Posted as of Jul 23, 2021