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

Not Applicable

Recruiting

• Conditions: Funnel Chest

• Registration Number: NCT03770390
• Lead Sponsor: University Hospital, Montpellier

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

Study Timeline

• Study First Submitted: 2018-12-04
• Study First Submitted QC: 2018-12-06
• Study First Posted: 2018-12-10
• Study Start: 2018-12-16
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08
• Primary Completion: 2023-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change in: Oxygen pulse (mL O2 / heart beat)	post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))	Recorded during incremental exercise testing.

Secondary Outcome Measures

Name	Time	Method
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))	Maximum heart rate during incremental exercise testing.
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))	Maximum oxygen consumption during incremental exercise testing.
Change in: VO2MAX (% predicted)	post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))	Maximum oxygen consumption during incremental exercise testing.
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))	Presence/absence of an anomaly in oxygen pulse during incremental exercise testing.
Change in: Ventilatory threshold (% of VO2MAX)	post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))	The ventilatory threshold during incremental exercise testing.
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))	The breathing reserved during incremental exercise testing.
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)	This is a general health related quality of life questionnaire.
The Body Esteem Scale	post-op (expected maximum of 4 years)	This questionnaire treats body esteem.
Blood pressure (average, mmHg)	during surgery (day 0)	Per-operative hemodynamic measures
Oxygen saturation (SpO2, %)	during surgery (day 0)	Per-operative hemodynamic measures
Indexed systolic ejection volume (ml/beat/m2)	during surgery (day 0)	Per-operative hemodynamic measures
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))
Pulse	during surgery (day 0)	Per-operative hemodynamic measures
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)	This questionnaire treats self esteem.
Cardiac index (liters/min/m^2)	during surgery (day 0)	Per-operative hemodynamic measures
Variation in ejection volume (%)	during surgery (day 0)	Per-operative hemodynamic measures
Cumulative dose of vasopressors	during surgery (day 0)	Per-operative hemodynamic measures

Trial Locations

Locations (1)

Hôpital Arnaud de Villeneuve - CHU de Montpellier; 🇫🇷 Montpellier, France