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Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction

Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03463798
Acronym
DYSDIA
Enrollment
125
Registered
2018-03-13
Start date
2018-06-11
Completion date
2021-09-21
Last updated
2023-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diaphragmatic Paralysis, Healthy Volunteers

Keywords

structured light plethysmography, sonar, transdiaphragmatic pressure

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.

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.

Interventions

DEVICESonar

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

DEVICEStructured light plethysmography (SLP)

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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
amplitude of displacement of thoraco-abdominal compartments10 minutesasymmetry of displacement of thoraco-abdominal compartments during tidal breathing and respiratory manoeuvres

Secondary

MeasureTime frameDescription
displacement speed of thoraco-abdominal compartments10 minutesasynchrony of displacement of thoraco-abdominal compartments during tidal breathing and respiratory manoeuvres measurement

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026