Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations (HeartSoar)
Primary Purpose
Funnel Chest
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Surgical correction of pectus excavatum
Sponsored by
About this trial
This is an interventional treatment trial for Funnel Chest
Eligibility Criteria
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)
Sites / Locations
- Hôpital Arnaud de Villeneuve - CHU de MontpellierRecruiting
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
The study population
Arm Description
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
Outcomes
Primary Outcome Measures
Change in: Oxygen pulse (mL O2 / heart beat)
Recorded during incremental exercise testing.
Secondary Outcome Measures
Change in: Body mass index (kg/m^2)
Change in: The presence/absence of dyspnea during exercise
Change in: The presence/absence of palpitations
Change in: The presence/absence of psychosocial impact
Change in: VO2MAX (ml/kg/min)
Maximum oxygen consumption during incremental exercise testing.
Change in: VO2MAX (% predicted)
Maximum oxygen consumption during incremental exercise testing.
Change in: Maximum heart rate (bpm)
Maximum heart rate during incremental exercise testing.
Change in: Presence/absence of an anomaly in oxygen pulse
Presence/absence of an anomaly in oxygen pulse during incremental exercise testing.
Change in: Ventilatory threshold (% of VO2MAX)
The ventilatory threshold during incremental exercise testing.
Change in: Breathing Reserve (% of maximum voluntary ventilation)
The breathing reserved during incremental exercise testing.
Change in: Forced expiratory volume in 1 second (liters)
Change in: Forced expiratory volume in 1 second (% predicted)
Change in: Forced vital capacity (liters)
Change in: Forced vital capacity (% predicted)
Change in: Forced expiratory volume in 1 second (litres) / forced vital capacity (litres)
Change in: Residual volume (liters)
Change in: Residual volume (% predicted)
Change in: Total lung capacity (liters)
Change in: Total lung capacity (% predicted)
Change in: Residual volume / Total lung capacity (liters/liters)
Change in: Functional residual capacity (liters)
Change in: Functional residual capacity (% predicted)
The SF36 questionnaire
This is a general health related quality of life questionnaire.
The Body Esteem Scale
This questionnaire treats body esteem.
The Rosenberg Self Esteem Scale
This questionnaire treats self esteem.
Complications
Blood pressure (average, mmHg)
Per-operative hemodynamic measures
Pulse
Per-operative hemodynamic measures
Oxygen saturation (SpO2, %)
Per-operative hemodynamic measures
Cardiac index (liters/min/m^2)
Per-operative hemodynamic measures
Variation in ejection volume (%)
Per-operative hemodynamic measures
Indexed systolic ejection volume (ml/beat/m2)
Per-operative hemodynamic measures
Cumulative dose of vasopressors
Per-operative hemodynamic measures
Full Information
NCT ID
NCT03770390
First Posted
December 4, 2018
Last Updated
September 7, 2023
Sponsor
University Hospital, Montpellier
1. Study Identification
Unique Protocol Identification Number
NCT03770390
Brief Title
Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations
Acronym
HeartSoar
Official Title
Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 16, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Montpellier
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of this study is to characterize the cardiorespiratory functional gain in patients with pectus excavatum following corrective surgery.
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Funnel Chest
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This single group study documents changes before and after surgical correction of pectus excavatum.
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
The study population
Arm Type
Other
Arm Description
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
Intervention Type
Procedure
Intervention Name(s)
Surgical correction of pectus excavatum
Intervention Description
Surgical correction of pectus excavatum
Primary Outcome Measure Information:
Title
Change in: Oxygen pulse (mL O2 / heart beat)
Description
Recorded during incremental exercise testing.
Time Frame
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Secondary Outcome Measure Information:
Title
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))
Title
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))
Title
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))
Title
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))
Title
Change in: VO2MAX (ml/kg/min)
Description
Maximum oxygen consumption during incremental exercise testing.
Time Frame
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Title
Change in: VO2MAX (% predicted)
Description
Maximum oxygen consumption during incremental exercise testing.
Time Frame
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Title
Change in: Maximum heart rate (bpm)
Description
Maximum heart rate during incremental exercise testing.
Time Frame
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Title
Change in: Presence/absence of an anomaly in oxygen pulse
Description
Presence/absence of an anomaly in oxygen pulse during incremental exercise testing.
Time Frame
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Title
Change in: Ventilatory threshold (% of VO2MAX)
Description
The ventilatory threshold during incremental exercise testing.
Time Frame
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Title
Change in: Breathing Reserve (% of maximum voluntary ventilation)
Description
The breathing reserved during incremental exercise testing.
Time Frame
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Title
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))
Title
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))
Title
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))
Title
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))
Title
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))
Title
Change in: Residual volume (liters)
Time Frame
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Title
Change in: Residual volume (% predicted)
Time Frame
post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Title
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))
Title
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))
Title
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))
Title
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))
Title
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))
Title
The SF36 questionnaire
Description
This is a general health related quality of life questionnaire.
Time Frame
post-op (expected maximum of 4 years)
Title
The Body Esteem Scale
Description
This questionnaire treats body esteem.
Time Frame
post-op (expected maximum of 4 years)
Title
The Rosenberg Self Esteem Scale
Description
This questionnaire treats self esteem.
Time Frame
post-op (expected maximum of 4 years)
Title
Complications
Time Frame
per-op up to expected maximum of 4 years
Title
Blood pressure (average, mmHg)
Description
Per-operative hemodynamic measures
Time Frame
during surgery (day 0)
Title
Pulse
Description
Per-operative hemodynamic measures
Time Frame
during surgery (day 0)
Title
Oxygen saturation (SpO2, %)
Description
Per-operative hemodynamic measures
Time Frame
during surgery (day 0)
Title
Cardiac index (liters/min/m^2)
Description
Per-operative hemodynamic measures
Time Frame
during surgery (day 0)
Title
Variation in ejection volume (%)
Description
Per-operative hemodynamic measures
Time Frame
during surgery (day 0)
Title
Indexed systolic ejection volume (ml/beat/m2)
Description
Per-operative hemodynamic measures
Time Frame
during surgery (day 0)
Title
Cumulative dose of vasopressors
Description
Per-operative hemodynamic measures
Time Frame
during surgery (day 0)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurence Solovei, MD
Phone
+33.(0)4.67.33.62.70
Email
l-solovei@chu-montpellier.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurence Solovei, MD
Organizational Affiliation
University Hospitals of Montpellier, France
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Arnaud de Villeneuve - CHU de Montpellier
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Solovei, MD
First Name & Middle Initial & Last Name & Degree
Arnaud Bourdin, MD, PhD
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Cardiorespiratory Assessment and Quality of Life After Surgical Correction of Congenital Wall Malformations
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