Clinical trial NCT02174796: Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities
Official title: Hemodynamic Repercussions of the Correction (Surgical and Non Surgical) of Pectus Excavatum-type Thoracic Deformities
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pectus Excavatum
Keywords: Pectus excavatum
cardiac output
transthoracic impedancemetry
Lead sponsor: Centre Jean Perrin
Sponsor class: OTHER
First posted: 2014-06-26
Enrollment: 41
Sex: ALL
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Cardiac output difference before and after intervention,during an exercise stress test
timeFrame: 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 outcomes:
measure: Rest lung function tests
timeFrame: 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)
measure: Exercise functional capacity
timeFrame: 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)
measure: Exercise cardiac output
timeFrame: 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)
measure: Quality of life
timeFrame: 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)
measure: Mean energy expenditure
timeFrame: 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)
measure: Evaluation of postoperative neuropathic pain
timeFrame: 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)
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand, Médecine du sport et d'explorations fonctionnelles
city: Clermont-Ferrand
country: France
facility: Centre Jean Perrin
city: Clermont-Ferrand
country: France
facility: CHU G Montpied, Service de Cardiologie et Maladies Vasculaires
city: Saint-Priest en Jarez
country: France
facility: CHU de St Etienne, Hôpital Nord, Chirurgie thoracique
city: St Etienne
country: France
facility: CHU de Saint-Étienne, Hôpital Bellevue, Médecine du Sport et explorations fonctionnelles
Study officials:
affiliation: Centre Jean Perrin, Service de Chirurgie Thoracique
name: Marc Filaire, Pr
role: PRINCIPAL_INVESTIGATOR
References: