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

University Hospital, Montpellier1 site in 1 country43 target enrollmentDecember 16, 2018

ConditionsFunnel Chest

Overview

Phase: N/A
Intervention: Not specified
Conditions: Funnel Chest
Sponsor: University Hospital, Montpellier
Enrollment: 43
Locations: 1
Primary Endpoint: Change in: Oxygen pulse (mL O2 / heart beat)
Status: Completed
Last Updated: 7 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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

Registry

clinicaltrials.gov

Start Date

December 16, 2018

End Date

December 31, 2024

Last Updated

7 months ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University Hospital, Montpellier

Responsible Party

Sponsor

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)

Outcomes

Primary Outcomes

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

Complications(per-op up to expected maximum of 4 years)
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: 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: 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: Maximum heart rate (bpm)(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: VO2MAX (ml/kg/min)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
Change in: VO2MAX (% predicted)(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(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
Change in: Ventilatory threshold (% of VO2MAX)(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)(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: Functional residual capacity (liters)(post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)))
The SF36 questionnaire(post-op (expected maximum of 4 years))
The Body Esteem Scale(post-op (expected maximum of 4 years))
Blood pressure (average, mmHg)(during surgery (day 0))
Oxygen saturation (SpO2, %)(during surgery (day 0))
Indexed systolic ejection volume (ml/beat/m2)(during surgery (day 0))
Pulse(during surgery (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 (% 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: Functional residual 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)))
The Rosenberg Self Esteem Scale(post-op (expected maximum of 4 years))
Cardiac index (liters/min/m^2)(during surgery (day 0))
Variation in ejection volume (%)(during surgery (day 0))
Cumulative dose of vasopressors(during surgery (day 0))