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Completed

NCT Number: NCT03770390

Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations

The main objective of this study is to characterize the cardiorespiratory functional gain in patients with pectus excavatum following corrective surgery.

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Key information

Conditions

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

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Arnaud de Villeneuve - CHU de Montpellier

Montpellier, 34295, France

About this study

The secondary objectives are:

  • To measure the quality of life of patients operated on for pectus excavatum
  • Identify and describe post-operative complications
  • Follow-up on the body mass index changes post-surgery
  • Evaluate intraoperative hemodynamic parameters before and after the retrosternal bar is placed non-invasively

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with pectus excavatum
  • The patient received corrective surgery within four years of enrollment and is scheduled for a follow-up visit --OR-- the patient is scheduled for corrective surgery during the inclusion period
  • Collection of informed written consent (patient and legal guardian, if applicable)
  • Obligation of affiliation or beneficiary of a social security programme

Exclusion criteria

  • Impossibility for the patient to participate in his/her next annual follow-up visit
  • Absence of exercise test data AND respiratory function test data performed during the preoperative check-up
  • Subject in exclusion period required by another protocol
  • Pregnant or lactating woman, patient unable to give consent, protected adult, vulnerable persons (according to French Health Code articles L.1121-6, L.1121-7, L.1211-8, L.1211-9)
  • Subject deprived of liberty by judicial or administrative decision
  • Participation of the subject in another interventional protocol
  • Failure to properly inform the patient (e.g. a language barrier)

Treatment and study plan

Surgical correction of pectus excavatum

Procedure

Surgical correction of pectus excavatum

Primary outcomes

  1. Change in: Oxygen pulse (mL O2 / heart beat)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

    Recorded during incremental exercise testing.

Secondary outcomes

  1. Change in: Body mass index (kg/m^2)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  2. Change in: The presence/absence of dyspnea during exercise

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  3. Change in: The presence/absence of palpitations

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  4. Change in: The presence/absence of psychosocial impact

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  5. Change in: VO2MAX (ml/kg/min)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

    Maximum oxygen consumption during incremental exercise testing.

  6. Change in: VO2MAX (% predicted)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

    Maximum oxygen consumption during incremental exercise testing.

  7. Change in: Maximum heart rate (bpm)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

    Maximum heart rate during incremental exercise testing.

  8. Change in: Presence/absence of an anomaly in oxygen pulse

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

    Presence/absence of an anomaly in oxygen pulse during incremental exercise testing.

  9. Change in: Ventilatory threshold (% of VO2MAX)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

    The ventilatory threshold during incremental exercise testing.

  10. Change in: Breathing Reserve (% of maximum voluntary ventilation)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

    The breathing reserved during incremental exercise testing.

  11. Change in: Forced expiratory volume in 1 second (liters)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  12. Change in: Forced expiratory volume in 1 second (% predicted)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  13. Change in: Forced vital capacity (liters)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  14. Change in: Forced vital capacity (% predicted)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  15. Change in: Forced expiratory volume in 1 second (litres) / forced vital capacity (litres)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  16. Change in: Residual volume (liters)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  17. Change in: Residual volume (% predicted)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  18. Change in: Total lung capacity (liters)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  19. Change in: Total lung capacity (% predicted)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  20. Change in: Residual volume / Total lung capacity (liters/liters)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  21. Change in: Functional residual capacity (liters)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  22. Change in: Functional residual capacity (% predicted)

    Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

  23. The SF36 questionnaire

    Time frame: post-op (expected maximum of 4 years)

    This is a general health related quality of life questionnaire.

  24. The Body Esteem Scale

    Time frame: post-op (expected maximum of 4 years)

    This questionnaire treats body esteem.

  25. The Rosenberg Self Esteem Scale

    Time frame: post-op (expected maximum of 4 years)

    This questionnaire treats self esteem.

  26. Complications

    Time frame: per-op up to expected maximum of 4 years

  27. Blood pressure (average, mmHg)

    Time frame: during surgery (day 0)

    Per-operative hemodynamic measures

  28. Pulse

    Time frame: during surgery (day 0)

    Per-operative hemodynamic measures

  29. Oxygen saturation (SpO2, %)

    Time frame: during surgery (day 0)

    Per-operative hemodynamic measures

  30. Cardiac index (liters/min/m^2)

    Time frame: during surgery (day 0)

    Per-operative hemodynamic measures

  31. Variation in ejection volume (%)

    Time frame: during surgery (day 0)

    Per-operative hemodynamic measures

  32. Indexed systolic ejection volume (ml/beat/m2)

    Time frame: during surgery (day 0)

    Per-operative hemodynamic measures

  33. Cumulative dose of vasopressors

    Time frame: during surgery (day 0)

    Per-operative hemodynamic measures

Sponsors and collaborators

Lead sponsor

University Hospital, Montpellier

Other

Registry information

Acronym: HeartSoar

Important dates

Study start
2018
Primary completion
2023
Study completion
2024
First posted
Dec 10, 2018
Registry last updated
Sep 30, 2025

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.

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