Skip to main content
OpenTrials
Completed

NCT Number: NCT02174796

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

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pectus Excavatum Bone Diseases Bone Diseases, Developmental Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Funnel Chest Musculoskeletal Abnormalities Musculoskeletal Diseases

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU G Montpied, Service de Cardiologie et Maladies Vasculaires, Clermont-Ferrand, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

surgical treatment

Procedure

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

orthopedic treatment

Procedure

orthopedic treatment by vacuum bell.

Primary outcomes

  1. Cardiac output difference before and after intervention,during an exercise stress test

    Time frame: 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 outcomes

  1. Rest lung function tests

    Time frame: 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)

  2. Exercise functional capacity

    Time frame: 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)

  3. Exercise cardiac output

    Time frame: 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)

  4. Quality of life

    Time frame: 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

  5. Mean energy expenditure

    Time frame: 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)

  6. Evaluation of postoperative neuropathic pain

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Centre Jean Perrin

Other

Registry information

Acronym: PECTUS

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Jun 26, 2014
Registry last updated
Jul 19, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.