Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities

Study Overview
=================
Brief Summary
-----------------
this non-randomized prospective study of 2 longitudinal cohorts (surgical treatment group or orthopedic treatment group), will evaluate the hemodynamic repercussions of the correction (surgical and non surgical) of pectus excavatum-type thoracic deformities by measuring the cardiac output difference before and after intervention, measured by transthoracic impedancemetry, during an exercise stress test

Official Title
-----------------
Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities

Conditions
-----------------
Pectus Excavatum

Intervention / Treatment
-----------------
* Procedure: surgical treatment
* Procedure: orthopedic treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients seeking treatment of a pectus excavatum Haller index > 3.2 Desire for treatment age between 15 and 40 years old Exclusion Criteria: Cognitive impairment Pregnancy Contraindication to exercise stress test or general anesthesia Coagulation disorders

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

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: Surgical treatment group<br>patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention). intervention: surgical correction (Ravitch or Nuss type intervention). | Procedure: surgical treatment<br>* patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention).<br>|
| Experimental: Orthopedic treatment group<br>patients who chose an orthopedic treatment by vacuum bell. intervention : orthopedic treatment by vacuum bell. | Procedure: orthopedic treatment<br>* orthopedic treatment by vacuum bell.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output difference before and after intervention,during an exercise stress test | Cardiac output measured by transthoracic impedancemetry, during an exercise stress test | 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rest lung function tests |  | 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3) | 
| Exercise functional capacity |  | 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3) | 
| Exercise cardiac output | Exercise cardiac output (measured by transthoracic echocardiography) | 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3) | 
| Quality of life | Quality of life SF36 | 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3) | 
| Mean energy expenditure | Mean energy expenditure will be evaluated by metabolic and physical activity monitor armband during 3 days (Kcal/min) | 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3) | 
| Evaluation of postoperative neuropathic pain |  | 4 months before treatment (initial evaluation E1) just before treatment (intermediate evaluation E2) and 4 months after surgical treatment (TC) or orthopedic treatment (TO) of the deformation (final evaluation E3) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pectus excavatum, cardiac output, transthoracic impedancemetry