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Clinical Trials/NCT03463798
NCT03463798
Completed
Not Applicable

Assesment of New Devices for the Diagnostic Evaluation of Diaphragmatic Dysfunction

Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil1 site in 1 country125 target enrollmentJune 11, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diaphragmatic Paralysis
Sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Enrollment
125
Locations
1
Primary Endpoint
amplitude of displacement of thoraco-abdominal compartments
Status
Completed
Last Updated
2 years ago

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.

Registry
clinicaltrials.gov
Start Date
June 11, 2018
End Date
September 21, 2021
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Association pour le Développement et l'Organisation de la Recherche en Pneumologie et sur le Sommeil
Responsible Party
Sponsor

Eligibility Criteria

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)

Study Sites (1)

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