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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03463798
Recruitment Status : Recruiting
First Posted : March 13, 2018
Last Update Posted : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil

Study Description
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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
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
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Study Type : Observational
Estimated 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 : June 11, 2018
Estimated Primary Completion Date : January 30, 2033
Estimated Study Completion Date : June 11, 2033
Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with a suspicion of diaphragmatic dysfunction and healthy volunteers without any medical condition.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463798


Contacts
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Contact: Marie-Cécile NIERAT, phD 0142178196 m-cecile.nierat@wanadoo.fr

Locations
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France
INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière Recruiting
Paris, France, 75013
Contact: Marie-Cécile Niérat, PhD    0142178196 ext 0033    m-cecile.nierat@wanadoo.fr   
Contact: Sophie Lavault, PhD    0142178196 ext 0033    sophie.lavault@aphp.fr   
Sub-Investigator: Capucine Morelot-Panzini, MD, PhD         
Sub-Investigator: Christian Straus, MD, PhD         
Sub-Investigator: Claudia Llontop, MD         
Principal Investigator: Pierantonio Laveneziana, MD, PhD         
Sub-Investigator: Marie-Cécile Niérat, PhD         
Sub-Investigator: Thomas Similowski, MD,PhD         
Sponsors and Collaborators
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Investigators
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Principal Investigator: Pierantonio LAVENEZIANA, MD, PhD UMRS_1158
More Information
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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: March 13, 2018    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
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:
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Respiratory Paralysis
Paralysis
Neurologic Manifestations
Nervous System Diseases
 Respiratory Insufficiency
Respiration Disorders
Respiratory Tract Diseases