The main objective of this study is to characterize the cardiorespiratory functional gain in patients with pectus excavatum following corrective surgery.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
43
Surgical correction of pectus excavatum
Hôpital Arnaud de Villeneuve - CHU de Montpellier
Montpellier, France
Change in: Oxygen pulse (mL O2 / heart beat)
Recorded during incremental exercise testing.
Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
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))
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))
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))
Change in: VO2MAX (ml/kg/min)
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))
Change in: VO2MAX (% predicted)
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))
Change in: Maximum heart rate (bpm)
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))
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Change in: Presence/absence of an anomaly in oxygen pulse
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))
Change in: Ventilatory threshold (% of VO2MAX)
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))
Change in: Breathing Reserve (% of maximum voluntary ventilation)
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))
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))
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))
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))
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))
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))
Change in: Residual volume (liters)
Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
Change in: Residual volume (% predicted)
Time frame: post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0))
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))
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))
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))
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))
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))
The SF36 questionnaire
This is a general health related quality of life questionnaire.
Time frame: post-op (expected maximum of 4 years)
The Body Esteem Scale
This questionnaire treats body esteem.
Time frame: post-op (expected maximum of 4 years)
The Rosenberg Self Esteem Scale
This questionnaire treats self esteem.
Time frame: post-op (expected maximum of 4 years)
Complications
Time frame: per-op up to expected maximum of 4 years
Blood pressure (average, mmHg)
Per-operative hemodynamic measures
Time frame: during surgery (day 0)
Pulse
Per-operative hemodynamic measures
Time frame: during surgery (day 0)
Oxygen saturation (SpO2, %)
Per-operative hemodynamic measures
Time frame: during surgery (day 0)
Cardiac index (liters/min/m^2)
Per-operative hemodynamic measures
Time frame: during surgery (day 0)
Variation in ejection volume (%)
Per-operative hemodynamic measures
Time frame: during surgery (day 0)
Indexed systolic ejection volume (ml/beat/m2)
Per-operative hemodynamic measures
Time frame: during surgery (day 0)
Cumulative dose of vasopressors
Per-operative hemodynamic measures
Time frame: during surgery (day 0)