Pectus Carinatum, Pectus Excavatum
Conditions
Keywords
Pectus Excavatum, Pectus Carinatum, Vacuum Bell, Dynamic compression system, Hearth variability, Autonomic Nervous System
Brief 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.
Interventions
DEVICEVacuum Bell
Patients will be submitted to a negative pressure treatment with the Vacuum Bell device.
Patients will be submitted to a dynamic compression system.
Sponsors
MEDICALEX
Centre Hospitalier Universitaire de Saint Etienne
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
10 Years to 30 Years
Healthy volunteers
No
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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| High frequency normalized index (HFnu) | One month after the end of treatment | It is a reflect of the RR short term heart rate variability (HRV) in the frequency domain. It is measured with a ECG Holter monitor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| LF/HF ratio | One month after the end of treatment | It is another index of RR heart rate variability (HRV) measured with a ECG holter monitor. |
| Blood pressure - Baroreflex | One month after the end of treatment | Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure |
| Lung residual volume | One month after the end of treatment | It is expressed in litres and is measured with a plethysmograph during a pulmonary function testing. |
| Maximum flow | One month after the end of treatment | It is expressed in litres per minute and is measured during a pulmonary function testing. The patient is seated and his/her nose is blocked with a clamp. He/She must blow as fast and as hard as possible. |
| Low frequency (LF and LFnu) | One month after the end of treatment | It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor. |
| Maximum heart rate | One month after the end of treatment | It is measured by a stress test (incremental exercise) |
| Left ventricular ejection fraction | One month after the end of treatment | It is measured by an echocardiography |
| Severity index of the anatomical damage | One month after the end of treatment | It is measured by a thoracic MRI. It is the ratio between the thoracic width and the distance sternum/spine. |
| Nuss Questionnaire | One month after the end of treatment | It is a depression scale |
| Aerobic maximum power | One month after the end of treatment | It is measured by a stress test (incremental exercise) |
Countries
France
Contacts
Primary ContactArnaud PATOIR, MD
Backup ContactArnauld GARCIN, CRA
Outcome results
None listed