Clinical Trials Directory

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

TypeNameDescription
DEVICEAcoustic reflection method evaluationEvaluation of airways by acoustic relection method, with and without the bracing device
RADIATIONEOS™Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device
OTHERNon invasive respiratory muscle assessmentNon 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.