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

September 7, 2023 updated by: University Hospital, Montpellier
The main objective of this study is to characterize the cardiorespiratory functional gain in patients with pectus excavatum following corrective surgery.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Montpellier, France, 34295
        • Recruiting
        • Hôpital Arnaud de Villeneuve - CHU de Montpellier
        • Principal Investigator:
          • Laurence Solovei, MD
        • Sub-Investigator:
          • Arnaud Bourdin, MD, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: The study population

Patients included in this study have pectus excavatum. The have either already undergone corrective surgery during the four years prior to the inclusion period, or are scheduled for surgery during the inclusion period.

Intervention: Surgical correction of pectus excavatum
Procedure: Surgical correction of pectus excavatum
Surgical correction of pectus excavatum

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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))
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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.
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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.
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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.
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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.
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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.
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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.
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Residual volume (liters)
Time Frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Residual volume (% predicted)
Time Frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
The SF36 questionnaire
Time Frame: post-op (expected maximum of 4 years)
This is a general health related quality of life questionnaire.
post-op (expected maximum of 4 years)
The Body Esteem Scale
Time Frame: post-op (expected maximum of 4 years)
This questionnaire treats body esteem.
post-op (expected maximum of 4 years)
The Rosenberg Self Esteem Scale
Time Frame: post-op (expected maximum of 4 years)
This questionnaire treats self esteem.
post-op (expected maximum of 4 years)
Complications
Time Frame: per-op up to expected maximum of 4 years
per-op up to expected maximum of 4 years
Blood pressure (average, mmHg)
Time Frame: during surgery (day 0)
Per-operative hemodynamic measures
during surgery (day 0)
Pulse
Time Frame: during surgery (day 0)
Per-operative hemodynamic measures
during surgery (day 0)
Oxygen saturation (SpO2, %)
Time Frame: during surgery (day 0)
Per-operative hemodynamic measures
during surgery (day 0)
Cardiac index (liters/min/m^2)
Time Frame: during surgery (day 0)
Per-operative hemodynamic measures
during surgery (day 0)
Variation in ejection volume (%)
Time Frame: during surgery (day 0)
Per-operative hemodynamic measures
during surgery (day 0)
Indexed systolic ejection volume (ml/beat/m2)
Time Frame: during surgery (day 0)
Per-operative hemodynamic measures
during surgery (day 0)
Cumulative dose of vasopressors
Time Frame: during surgery (day 0)
Per-operative hemodynamic measures
during surgery (day 0)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Investigators

  • Principal Investigator: Laurence Solovei, MD, University Hospitals of Montpellier, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2018

Primary Completion (Estimated)

December 31, 2023

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

December 4, 2018

First Submitted That Met QC Criteria

December 6, 2018

First Posted (Actual)

December 10, 2018

Study Record Updates

Last Update Posted (Actual)

September 8, 2023

Last Update Submitted That Met QC Criteria

September 7, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 7650 (CTEP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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