HEMO-INTEGRA: Integrated Intraoperative Hemodynamic Monitoring During Cardiac Surgery With Cardiopulmonary Bypass - A Pilot Study

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHernán Darío Castro Arias

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

30 Participants
are grouped into 1 trial group

Sponsors and collaborators

Hernán Darío Castro Arias

Lead sponsor

Hernán Darío Castro Arias MD MSc

Sponsor institution