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

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

Study Overview

• Status: Completed
• Conditions: Pectus Excavatum
• Intervention / Treatment: Procedure: surgical treatment; Procedure: orthopedic treatment

• Study Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63011
    • Centre Jean Perrin
  • Clermont-Ferrand, France, 63000
    • CHU de Clermont-Ferrand, Médecine du sport et d'explorations fonctionnelles
  • Clermont-Ferrand, France, 63011
    • CHU G Montpied, Service de Cardiologie et Maladies Vasculaires
  • Saint-Priest en Jarez, France, 42055
    • CHU de St Etienne, Hôpital Nord, Chirurgie thoracique
  • St Etienne, France, 42100
    • CHU de Saint-Étienne, Hôpital Bellevue, Médecine du Sport et explorations fonctionnelles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 40 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Surgical treatment group; patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention). intervention: surgical correction (Ravitch or Nuss type intervention).	Procedure: surgical treatment; patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention).
EXPERIMENTAL: Orthopedic treatment group; patients who chose an orthopedic treatment by vacuum bell. intervention : orthopedic treatment by vacuum bell.	Procedure: orthopedic treatment; orthopedic treatment by vacuum bell.

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)

Collaborators and Investigators

• Sponsor: Centre Jean Perrin
• Investigators: Principal Investigator: Marc Filaire, Pr, Centre Jean Perrin, Service de Chirurgie Thoracique

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 5, 2014
• Primary Completion (ACTUAL): February 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: April 23, 2014
• First Submitted That Met QC Criteria: June 24, 2014
• First Posted (ESTIMATE): June 26, 2014

Study Record Updates

• Last Update Posted (ACTUAL): July 19, 2017
• Last Update Submitted That Met QC Criteria: July 18, 2017
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Keywords: cardiac output; Pectus excavatum; transthoracic impedancemetry
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Bone Diseases; Musculoskeletal Abnormalities; Bone Diseases, Developmental; Funnel Chest
• Other Study ID Numbers: 2013-A01811-44