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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 10
Maximum Age: 30
Healthy Volunteers: f
View:

• Patient with pectus excavatum or pectus carinatum who does not require surgery

• Patient with sufficient displacement of the chest wall during an initial test carried out during the first consultation :For pectus carinatum correction must be obtained with a pressure lower than 9 psi (pound per square inch). For pectus excavatum less than 250 mbar depression.

• Signed informed consent

• Subject (or parents) affiliated to the French National Health Insurance

Locations
Other Locations
France
CHU de SAINT-ETIENNE
RECRUITING
Saint-etienne
Contact Information
Primary
Arnaud PATOIR, MD
arnaud.patoir@chu-st-etienne.fr
(0)477828847
Backup
Arnauld GARCIN, CRA
arnauld.garcin@chu-st-etienne.fr
(0)477120286
Time Frame
Start Date: 2015-01-12
Estimated Completion Date: 2024-06
Participants
Target number of participants: 52
Treatments
Experimental: Pectus Excavatum
Patients with pectus excavatum who do not require surgery, will be treated with the Vacuum bell device.
Experimental: Pectus Carinatum
Patients with pectus carinatum who do not require surgery, will be treated with the Dynamic Compression System.
Related Therapeutic Areas
Sponsors
Collaborators: MEDICALEX
Leads: Centre Hospitalier Universitaire de Saint Etienne

This content was sourced from clinicaltrials.gov