About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
- Adult patients 18 years or older scheduled for elective cardiac surgery with cardiopulmonary bypass
Standard intraoperative TEE and arterial line monitoring in place
Written informed consent obtained
Disqualifiers
- Emergency surgery
Off-pump cardiac surgery (OPCAB)
Inability to obtain adequate TEE window
Refusal to participate
Trial population
Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass at Clinica Medellin Sede Occidente, Medellin, Colombia.
Trial design
Cohort
Prospective
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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Hernán Darío Castro Arias
Lead sponsor
Hernán Darío Castro Arias MD MSc
Sponsor institution