Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction
NCT ID: NCT03463798
Last Updated: 2023-09-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
125 participants
OBSERVATIONAL
2018-06-11
2021-09-21
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patients
Patients with a suspicion of diaphragmatic dysfunction
Sonar
Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly
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
Sonar
Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly
Structured light plethysmography (SLP)
Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly
Interventions
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Sonar
Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly
Structured light plethysmography (SLP)
Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly
Eligibility Criteria
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Inclusion Criteria
* no neurologic disease
* no thoracic deformation
* patients with a suspicion of diaphragmatic dysfunction
Exclusion Criteria
* neurologic disease
* thoracic deformation
FOR PATIENTS
* pregnant women
* contraindications to standard procedure requiring transdiaphragmatic measurement
18 Years
ALL
Yes
Sponsors
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Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
OTHER
Responsible Party
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Principal Investigators
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Pierantonio LAVENEZIANA, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
UMRS_1158
Locations
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INSERM-UPC UMR_S 1158 Service de Pneumologie et Réanimation, R3S, Groupe Hospitalier Pitié-Salpêtrière
Paris, , France
Countries
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Other Identifiers
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2017-A03665-48
Identifier Type: -
Identifier Source: org_study_id
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