Pectus Excavatum
Conditions
Keywords
Pectus excavatum, cardiac output, transthoracic impedancemetry
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
Interventions
PROCEDUREsurgical treatment
patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention).
PROCEDUREorthopedic treatment
orthopedic treatment by vacuum bell.
Sponsors
Centre Jean Perrin
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac output difference before and after intervention,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) | Cardiac output measured by transthoracic impedancemetry, during an exercise stress test |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 (measured by transthoracic echocardiography) |
| 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) | — |
| Mean energy expenditure | 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 will be evaluated by metabolic and physical activity monitor armband during 3 days (Kcal/min) |
| 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) | — |
| Quality of life | 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 SF36 |
Countries
France
Outcome results
None listed