Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 125
- Locations
- 1
- Primary Endpoint
- amplitude of displacement of thoraco-abdominal compartments
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Outcomes
Primary Outcomes
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
- displacement speed of thoraco-abdominal compartments(10 minutes)