CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 15 enrolled
Drug / intervention
Acoustic reflection method evaluation +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01087034
NCT01087034N/ACompleted

Bracing During Infantile Scoliosis: Airways Study by Acoustic Method, EOS™ Acquisition and Noninvasive Respiratory Muscles Assessment

Club d'Anesthésie-Réanimation Pédiatrique Armand Trousseau·observational·Posted Mar 15, 2010·Updated Jun 12, 2012

In Brief

An observational study evaluating Acoustic reflection method evaluation, EOS™, and 1 other intervention for Scoliosis. Completed, enrolled 15 participants across 2 sites.

Detailed 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™)

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsScoliosis
CountriesFrance

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 15, 2010
Enrollment StartFeb 1, 2010
Primary CompletionJul 1, 2010
Study CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.3 years ago

Interventions

Acoustic reflection method evaluationdevice

Evaluation of airways by acoustic relection method, with and without the bracing device

EOS™radiation

Scoliosis and thoracic penetration index evaluation by EOS™ acquisition, with and without the bracing device

Non invasive respiratory muscle assessmentother

Non invasive respiratory muscles assessment, with and without the bracing device.