RecruitingNCT07683299

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


Sponsor

Hernán Darío Castro Arias

Enrollment

30 participants

Start Date

May 27, 2026

Study Type

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

Min Age: 18 Years

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)

Clinica Medellin Sede Occidente

Medellín, Antioquia, Colombia

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NCT07683299


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