NCT02528656

Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities

Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities. Pectus Excavatum Pectus-Carinatum. Single-center Study

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (estimated)
• Sponsor: Centre Hospitalier Universitaire de Saint Etienne · Academic / Other
• Sex: All
• Age: 10 Years – 30 Years
• Healthy volunteers: Not accepted

Summary

The physiological assessment in non-operative treatment on chest wall deformities, are still unclear today. These functional benefits outweigh the aesthetic benefits associated with anatomical improvement. The functional benefits, ventilation, hemodynamic and neurologic, have never been evaluated. Assessment of Effects on parasympathetic activity of the autonomic nervous system, global health criterion measured by noninvasive methods. Anatomic evaluation, between the initial and final assessment by objective measures 1) of the chest wall by MRI, and 2) of the heart by echocardiography. Noninvasive physiological assessment at rest and during exercise in respiratory function exploration flows and volumes, cardiac function by flow measurement, and overall metabolic function test effort (VO2max). Subjective assessment of functional gain between the initial and final balance sheet, based on EVA scales, valued by patients, parents and doctors.

Conditions

• Pectus Excavatum
• Pectus Carinatum

Interventions

Type	Name	Description
DEVICE	Vacuum Bell	Patients will be submitted to a negative pressure treatment with the Vacuum Bell device.
DEVICE	Dynamic Compression System	Patients will be submitted to a dynamic compression system.

Timeline

• Start date: 2015-01-12
• Primary completion: 2024-06-01
• Completion: 2024-06-01
• First posted: 2015-08-19
• Last updated: 2024-04-22

Locations

1 site across 1 country: France