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

Pectus Excavatum Clinical Trial

— PECTUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02174796
• Other study ID #: 2013-A01811-44
• Status: Completed
• Phase: N/A
• First received: April 23, 2014
• Last updated: July 18, 2017
• Start date: May 5, 2014
• Est. completion date: July 2017

Study information

• Verified date: July 2017
• Source: Centre Jean Perrin
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Congenital Abnormalities
• Funnel Chest
• Pectus Excavatum

Intervention

Procedure:
• surgical treatment
patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention).
• orthopedic treatment
orthopedic treatment by vacuum bell.

Locations

Country	Name	City	State
France	Centre Jean Perrin	Clermont-Ferrand
France	CHU de Clermont-Ferrand, Médecine du sport et d'explorations fonctionnelles	Clermont-Ferrand
France	CHU G Montpied, Service de Cardiologie et Maladies Vasculaires	Clermont-Ferrand
France	CHU de St Etienne, Hôpital Nord, Chirurgie thoracique	Saint-Priest en Jarez
France	CHU de Saint-Étienne, Hôpital Bellevue, Médecine du Sport et explorations fonctionnelles	St Etienne

Sponsors (1)

Lead Sponsor	Collaborator
Centre Jean Perrin

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)