Informations générales (source: ClinicalTrials.gov)
Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities. Pectus Excavatum Pectus-Carinatum. Single-center Study (PECTUS)
Interventional
N/A
Centre Hospitalier Universitaire de Saint Etienne (Voir sur ClinicalTrials)
janvier 2015
juin 2024
29 juin 2024
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.
Etablissements
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| CHU de SAINT-ETIENNE - 42000 - Saint-etienne - France | Contact (sur clinicalTrials) | ||||
Critères
Tous
Inclusion Criteria:
- 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
- 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
- Skeletal disease, disturbing bone strength as osteogenesis imperfect and
osteoporosis.
- Uncontrolled coagulopathies.
- Marfan syndrome, with mitral valve prolapse for pectus Excavatum.
- Atrial fibrillation
- Taking antiarrhythmic drug.