Physiological Assessments During Non Operative Treatment on the Chest Wall Deformities

Study Overview
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Brief Summary
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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.

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

Conditions
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Pectus Excavatum, Pectus Carinatum

Intervention / Treatment
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* Device: Vacuum Bell
* Device: Dynamic Compression System


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pectus Excavatum<br>Patients with pectus excavatum who do not require surgery, will be treated with the Vacuum bell device. | Device: Vacuum Bell<br>* Patients will be submitted to a negative pressure treatment with the Vacuum Bell device.<br>|
| Experimental: Pectus Carinatum<br>Patients with pectus carinatum who do not require surgery, will be treated with the Dynamic Compression System. | Device: Dynamic Compression System<br>* Patients will be submitted to a dynamic compression system.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| High frequency normalized index (HFnu) | 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 | One month after the end of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low frequency (LF and LFnu) | It is another index of RR heart rate variability (HRV) measured with a ECG Holter monitor. | One month after the end of treatment | 
| LF/HF ratio | It is another index of RR heart rate variability (HRV) measured with a ECG holter monitor. | One month after the end of treatment | 
| Blood pressure - Baroreflex | Measure of autonomic function (parasympathetic activity) - quantified via changes in blood pressure | One month after the end of treatment | 
| Lung residual volume | It is expressed in litres and is measured with a plethysmograph during a pulmonary function testing. | One month after the end of treatment | 
| Maximum flow | 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. | One month after the end of treatment | 
| Aerobic maximum power | It is measured by a stress test (incremental exercise) | One month after the end of treatment | 
| Maximum heart rate | It is measured by a stress test (incremental exercise) | One month after the end of treatment | 
| Left ventricular ejection fraction | It is measured by an echocardiography | One month after the end of treatment | 
| Severity index of the anatomical damage | It is measured by a thoracic MRI. It is the ratio between the thoracic width and the distance sternum/spine. | One month after the end of treatment | 
| Nuss Questionnaire | It is a depression scale | One month after the end of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pectus Excavatum, Pectus Carinatum, Vacuum Bell, Dynamic compression system, Hearth variability, Autonomic Nervous System