HEMO-INTEGRA: Integrated Intraoperative Hemodynamic Monitoring During Cardiac Surgery With Cardiopulmonary Bypass - A Pilot Study
HEMO-INTEGRA: Feasibility and Description of an Integrated Intraoperative Hemodynamic Monitoring System for Cardiac Surgery With Cardiopulmonary Bypass - A Pilot Observational Study
Hernán Darío Castro Arias
30 participants
May 27, 2026
OBSERVATIONAL
Conditions
Summary
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
Inclusion Criteria3
- \- 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
Exclusion Criteria4
- \- Emergency surgery
- Off-pump cardiac surgery (OPCAB)
- Inability to obtain adequate TEE window
- Refusal to participate
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Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07683299