Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction

NCT03463798 | Completed

• 1 other identifier: 2017-A03665-48
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

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.

Conditions

Diaphragmatic Paralysis; Healthy Volunteers

Keywords

structured light plethysmography; sonar; transdiaphragmatic pressure

Outcome Measures

Primary Outcomes (1)

• amplitude of displacement of thoraco-abdominal compartments

  asymmetry of displacement of thoraco-abdominal compartments during tidal breathing and respiratory manoeuvres

  10 minutes

Secondary Outcomes (1)

• displacement speed of thoraco-abdominal compartments

  10 minutes

Study Arms (2)

Patients

Patients with a suspicion of diaphragmatic dysfunction

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

Healthy volunteers

Subjects without any medical condition

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

Interventions

Sonar DEVICE

Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly

Healthy volunteers; Patients

Structured light plethysmography (SLP) DEVICE

Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly

Healthy volunteers; Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• no respiratory disease
• no neurologic disease
• no thoracic deformation

You may not qualify if:

• respiratory disease
• neurologic disease
• thoracic deformation
• FOR PATIENTS
• patients with a suspicion of diaphragmatic dysfunction
• pregnant women
• contraindications to standard procedure requiring transdiaphragmatic measurement

Sponsors & Collaborators

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

Study Sites (1)

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

Paris, 75013, France

Location

MeSH Terms

Conditions

Respiratory Paralysis

Condition Hierarchy (Ancestors)

Respiratory Insufficiency; Respiration Disorders; Respiratory Tract Diseases; Paralysis; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Pierantonio LAVENEZIANA, MD, PhD

  UMRS_1158

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2018
• First Posted: March 13, 2018
• Study Start: June 11, 2018
• Primary Completion: September 21, 2021
• Study Completion: September 21, 2021
• Last Updated: September 14, 2023

Record last verified: 2023-09

Locations

FR (1)