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Completed

NCT Number: NCT03463798

Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Paris, 75013, France

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sonar

Device

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

Structured light plethysmography (SLP)

Device

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

Primary outcomes

  1. amplitude of displacement of thoraco-abdominal compartments

    Time frame: 10 minutes

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

Secondary outcomes

  1. displacement speed of thoraco-abdominal compartments

    Time frame: 10 minutes

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

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Acronym: DYSDIA

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Mar 13, 2018
Registry last updated
Sep 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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