NCT02174796

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2014

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 23, 2014

Completed
12 days until next milestone

Study Start

First participant enrolled

May 5, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 26, 2014

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

July 19, 2017

Status Verified

July 1, 2017

Enrollment Period

2.7 years

First QC Date

April 23, 2014

Last Update Submit

July 18, 2017

Conditions

Pectus Excavatum

Keywords

Pectus excavatumcardiac outputtransthoracic impedancemetry

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • 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

    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)

  • 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)

  • +1 more secondary outcomes

Study Arms (2)

Surgical treatment group

EXPERIMENTAL

patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention). intervention: surgical correction (Ravitch or Nuss type intervention).

Procedure: surgical treatment

Orthopedic treatment group

EXPERIMENTAL

patients who chose an orthopedic treatment by vacuum bell. intervention : orthopedic treatment by vacuum bell.

Procedure: orthopedic treatment

Interventions

surgical treatmentPROCEDURE

patients who chose to undergo a surgical correction (Ravitch or Nuss type intervention).

Surgical treatment group
orthopedic treatmentPROCEDURE

orthopedic treatment by vacuum bell.

Orthopedic treatment group

Eligibility Criteria

Age15 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients seeking treatment of a pectus excavatum
  • Haller index \> 3.2
  • Desire for treatment
  • age between 15 and 40 years old

You may not qualify if:

  • Cognitive impairment
  • Pregnancy
  • Contraindication to exercise stress test or general anesthesia
  • Coagulation disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

CHU de Clermont-Ferrand, Médecine du sport et d'explorations fonctionnelles

Clermont-Ferrand, 63000, France

Location

Centre Jean Perrin

Clermont-Ferrand, 63011, France

Location

CHU G Montpied, Service de Cardiologie et Maladies Vasculaires

Clermont-Ferrand, 63011, France

Location

CHU de Saint-Étienne, Hôpital Bellevue, Médecine du Sport et explorations fonctionnelles

Saint-Etienne, 42100, France

Location

CHU de St Etienne, Hôpital Nord, Chirurgie thoracique

Saint-Priest-en-Jarez, 42055, France

Location

MeSH Terms

Conditions

Funnel Chest

Interventions

Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Bone Diseases, DevelopmentalBone DiseasesMusculoskeletal DiseasesMusculoskeletal AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Marc Filaire, Pr

    Centre Jean Perrin, Service de Chirurgie Thoracique

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2014

First Posted

June 26, 2014

Study Start

May 5, 2014

Primary Completion

February 1, 2017

Study Completion

July 1, 2017

Last Updated

July 19, 2017

Record last verified: 2017-07

Locations

FR(5)