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
Qualifiers
- 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 design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
Hernán Darío Castro Arias
Lead sponsor
Hernán Darío Castro Arias MD MSc
Sponsor institution