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

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

Detailed Description
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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

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

Conditions
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Funnel Chest

Intervention / Treatment
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* Procedure: Surgical correction of pectus excavatum


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 14 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This single group study documents changes before and after surgical correction of pectus excavatum.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: The study population<br>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<br>* Surgical correction of pectus excavatum<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in: Oxygen pulse (mL O2 / heart beat) | 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) |  | 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 |  | post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)) | 
| Change in: The presence/absence of palpitations |  | 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 |  | post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)) | 
| Change in: VO2MAX (ml/kg/min) | 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) | 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) | 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 | 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) | 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) | 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) |  | 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) |  | post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)) | 
| Change in: Forced vital capacity (liters) |  | post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)) | 
| Change in: Forced vital capacity (% predicted) |  | 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) |  | post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)) | 
| Change in: Residual volume (liters) |  | post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)) | 
| Change in: Residual volume (% predicted) |  | post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)) | 
| Change in: Total lung capacity (liters) |  | post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)) | 
| Change in: Total lung capacity (% predicted) |  | 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) |  | post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)) | 
| Change in: Functional residual capacity (liters) |  | post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)) | 
| Change in: Functional residual capacity (% predicted) |  | post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)) | 
| The SF36 questionnaire | This is a general health related quality of life questionnaire. | post-op (expected maximum of 4 years) | 
| The Body Esteem Scale | This questionnaire treats body esteem. | post-op (expected maximum of 4 years) | 
| The Rosenberg Self Esteem Scale | This questionnaire treats self esteem. | post-op (expected maximum of 4 years) | 
| Complications |  | per-op up to expected maximum of 4 years | 
| Blood pressure (average, mmHg) | Per-operative hemodynamic measures | during surgery (day 0) | 
| Pulse | Per-operative hemodynamic measures | during surgery (day 0) | 
| Oxygen saturation (SpO2, %) | Per-operative hemodynamic measures | during surgery (day 0) | 
| Cardiac index (liters/min/m^2) | Per-operative hemodynamic measures | during surgery (day 0) | 
| Variation in ejection volume (%) | Per-operative hemodynamic measures | during surgery (day 0) | 
| Indexed systolic ejection volume (ml/beat/m2) | Per-operative hemodynamic measures | during surgery (day 0) | 
| Cumulative dose of vasopressors | Per-operative hemodynamic measures | during surgery (day 0) |