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

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

Recruiting
18 years and older
All
Phase N/A

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Overview

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 Criteria:

  • \- 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 Criteria:

  • \- Emergency surgery
  • Off-pump cardiac surgery (OPCAB)
  • Inability to obtain adequate TEE window
  • Refusal to participate

Study details
    Cardiac Surgery
    Cardiopulmonary Bypass
    Hemodynamic Monitoring
    Ventricular-Arterial Coupling

NCT07683299

Hernán Darío Castro Arias

11 July 2026

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