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

Funnel Chest Clinical Trial

— HeartSoar  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03770390
• Other study ID #: 7650
• Status: Recruiting
• Phase: N/A
• Start date: December 16, 2018
• Est. completion date: December 31, 2024

Study information

• Verified date: September 2023
• Source: University Hospital, Montpellier
• Contact: Laurence Solovei, MD
• Phone: +33.(0)4.67.33.62.70
• Email: l-solovei[@]chu-montpellier.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Funnel Chest

Intervention

Procedure:
• Surgical correction of pectus excavatum
Surgical correction of pectus excavatum

Locations

Country	Name	City	State
France	Hôpital Arnaud de Villeneuve - CHU de Montpellier	Montpellier

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Montpellier

Country where clinical trial is conducted

France, 

Outcome

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