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| ID | Type | Description | Link |
|---|---|---|---|
| 2018-A01574-51 | Registry Identifier | ID-RCB |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study population | Other | Patients included in this study have pectus excavatum. The have either already undergone corrective surgery during the four years prior to the inclusion period, or are scheduled for surgery during the inclusion period. Intervention: Surgical correction of pectus excavatum |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgical correction of pectus excavatum | Procedure | Surgical correction of pectus excavatum |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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)) |
| Measure | Description | Time Frame |
|---|---|---|
| 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)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laurence Solovei, MD | University Hospitals of Montpellier, France | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital Arnaud de Villeneuve - CHU de Montpellier | Montpellier | 34295 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37321811 | Derived | Suehs CM, Molinari N, Bourdin A, Solovei L. Change in cardiorespiratory parameters following surgical correction of pectus excavatum: protocol for the historical-prospective HeartSoar cohort. BMJ Open. 2023 Jun 15;13(6):e070891. doi: 10.1136/bmjopen-2022-070891. |
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| ID | Term |
|---|---|
| D005660 | Funnel Chest |
| ID | Term |
|---|---|
| D001848 | Bone Diseases, Developmental |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D009139 | Musculoskeletal Abnormalities |
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This single group study documents changes before and after surgical correction of pectus excavatum.
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| 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) | Maximum oxygen consumption during incremental exercise testing. | 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. | 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. | 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 | 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)) |
| 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)) |
| 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)) |
| 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: Total lung capacity (liters) | 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 | This is a general health related quality of life questionnaire. | post-op (expected maximum of 4 years) |
| The Body Esteem Scale | This questionnaire treats body esteem. | post-op (expected maximum of 4 years) |
| The Rosenberg Self Esteem Scale | This questionnaire treats self esteem. | post-op (expected maximum of 4 years) |
| Complications | per-op up to expected maximum of 4 years |
| Blood pressure (average, mmHg) | Per-operative hemodynamic measures | during surgery (day 0) |
| Pulse | Per-operative hemodynamic measures | during surgery (day 0) |
| Oxygen saturation (SpO2, %) | Per-operative hemodynamic measures | during surgery (day 0) |
| Cardiac index (liters/min/m^2) | Per-operative hemodynamic measures | during surgery (day 0) |
| Variation in ejection volume (%) | Per-operative hemodynamic measures | during surgery (day 0) |
| Indexed systolic ejection volume (ml/beat/m2) | Per-operative hemodynamic measures | during surgery (day 0) |
| Cumulative dose of vasopressors | Per-operative hemodynamic measures | during surgery (day 0) |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |