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HEMO-INTEGRA is a software system that integrates four domains of intraoperative hemodynamic monitoring in a single dashboard during cardiac surgery with cardiopulmonary bypass (CPB): (1) ventricular-arterial coupling (VAC) analysis using the Balan 2026 method; (2) tissue perfusion and oxygen delivery (EPOC module with Q10 temperature correction); (3) neuromonitoring (NIRS/BIS); and (4) systemic venous congestion assessment via VExUS-TEE (Waldron 2024 method).
This pilot observational study evaluates the feasibility and completeness of data capture using HEMO-INTEGRA across five perioperative time points (T0: pre-CPB; T1: early CPB; T2: mid-CPB; T3: rewarming; T4: post-CPB) in adult patients undergoing elective cardiac surgery at Clinica Medellin Sede Occidente, Medellin, Colombia.
The system operates in parallel with standard monitoring and does not modify clinical management. No additional procedures are performed on participants beyond standard of care.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HEMO-INTEGRA Cohort | Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass monitored with the HEMO-INTEGRA integrated hemodynamic monitoring system across five intraoperative time points (T0 to T4). Intervention Name : HEMO-INTEGRA v2.0 Software system for integrated intraoperative hemodynamic monitoring integrating ventricular-arterial coupling (Balan 2026), tissue perfusion (EPOC/Q10), neuromonitoring (NIRS/BIS), and venous congestion (VExUS-TEE). Operates in parallel with standard care without modifying clinical management. |
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| Measure | Description | Time Frame |
|---|---|---|
| Data Capture Completeness | Proportion of cases with complete data capture across all five intraoperative time points (T0 to T4) for all four HEMO-INTEGRA monitoring modules: ventricular-arterial coupling, tissue perfusion, neuromonitoring, and venous congestion assessment. | Intraoperative (0 to 6 hours) |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass at Clinica Medellin Sede Occidente, Medellin, Colombia.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hernan D Castro-Arias, MD MSc | Contact | +573128633884 | hernan_castro@icloud.com |
| Name | Affiliation | Role |
|---|---|---|
| Hernan D Castro-Arias, MD MSc | Clinica Medellin Sede Occidente, Grupo Quiron Salud | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Medellin Sede Occidente | Recruiting | MedellĂn | Antioquia | Colombia |
Individual participant data will not be shared due to the pilot nature of this study and local institutional privacy regulations. Aggregate results will be reported in peer-reviewed publications.
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