Trials / Completed
CompletedNCT01087034
Bracing During Infantile Scoliosis: Airways Study
Bracing During Infantile Scoliosis: Airways Study by Acoustic Method, EOS™ Acquisition and Noninvasive Respiratory Muscles Assessment
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 15 (actual)
- Sponsor
- Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau · Academic / Other
- Sex
- All
- Age
- 6 Years – 18 Years
- Healthy volunteers
- Not accepted
Summary
Idiopathic juvenile thoracic scoliosis is a tridimensional deformation of the spine which may impact on the intrathoracic organs. Bracing is one of the oldest treatments of spinal deformities. It relies on the indirect manipulation of spinal curvatures in order to prevent curve progression, which may affect respiratory function. The acoustic reflection method is based on the analysis of the reflection of a single transient planar wave giving the longitudinal cross-sectional area profile of the examined cavity. It is noninvasive and harmless. The EOS™ device allows a double incidence, full body, and low-dose X-ray acquisition with thoracic 3D reconstruction. The aim of the study is to evaluate the impact of bracing on the upper airways patency (by means of the acoustic method), on the breathing pattern (noninvasive respiratory muscles assessment), and on the thoracic penetration index (by means of the EOS™)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Acoustic reflection method evaluation | Evaluation of airways by acoustic relection method, with and without the bracing device |
| RADIATION | EOS™ | Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device |
| OTHER | Non invasive respiratory muscle assessment | Non invasive respiratory muscles assessment, with and without the bracing device. |
Timeline
- Start date
- 2010-02-01
- Primary completion
- 2010-07-01
- Completion
- 2011-06-01
- First posted
- 2010-03-15
- Last updated
- 2012-06-12
Locations
2 sites across 1 country: France
Source: ClinicalTrials.gov record NCT01087034. Inclusion in this directory is not an endorsement.