An observational study in Diaphragmatic Paralysis and Healthy Volunteers, sponsored by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil. Completed at 1 site in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-09-14.
Sponsored by Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil · Observational
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.
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.
36 studies on the registry are indexed under Respiratory Paralysis; 9 are open to participants now.
This study's enrollment of 125 is above the median of 66 across 15 observational studies indexed under Respiratory Paralysis.
Browse Respiratory Paralysis studies →Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil is the lead sponsor of 22 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with a suspicion of diaphragmatic dysfunction and healthy volunteers without any medical condition.
FOR HEALTHY VOLUNTEERS
Inclusion Criteria:
Exclusion criteria
FOR PATIENTS
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients with a suspicion of diaphragmatic dysfunction
Device: Sonar · Device: Structured light plethysmography (SLP)
Subjects without any medical condition
Device: Sonar · Device: Structured light plethysmography (SLP)
Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly
Measurements of chest wall and abdominal wall movement will be performed while subjects are breathing quietly
amplitude of displacement of thoraco-abdominal compartments
asymmetry of displacement of thoraco-abdominal compartments during tidal breathing and respiratory manoeuvres
Time frame: 10 minutes
displacement speed of thoraco-abdominal compartments
asynchrony of displacement of thoraco-abdominal compartments during tidal breathing and respiratory manoeuvres measurement
Time frame: 10 minutes
Ran from Jun 2018 to primary completion in Sep 2021, 39 months.
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This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil