Funnel Chest
Conditions
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
Interventions
PROCEDURESurgical correction of pectus excavatum
Surgical correction of pectus excavatum
Sponsors
University Hospital, Montpellier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This single group study documents changes before and after surgical correction of pectus excavatum.
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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: 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: 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: 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: 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: 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 | 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. |
| The Rosenberg Self Esteem Scale | post-op (expected maximum of 4 years) | This questionnaire treats self esteem. |
| Complications | per-op up to expected maximum of 4 years | — |
| Blood pressure (average, mmHg) | during surgery (day 0) | Per-operative hemodynamic measures |
| Pulse | during surgery (day 0) | Per-operative hemodynamic measures |
| Oxygen saturation (SpO2, %) | during surgery (day 0) | Per-operative hemodynamic measures |
| 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 |
| Indexed systolic ejection volume (ml/beat/m2) | during surgery (day 0) | Per-operative hemodynamic measures |
| Cumulative dose of vasopressors | during surgery (day 0) | Per-operative hemodynamic measures |
| Change in: Total lung capacity (liters) | post-op (expected maximum of 4 years) versus pre-op (approximately month -1 up to day 0)) | — |
Countries
France
Outcome results
None listed