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

Recruiting now

Conditions studied: Cardiac Surgery, Cardiopulmonary Bypass, Hemodynamic Monitoring, Ventricular-Arterial Coupling

In brief

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.

Key facts

Study ID

NCT07683299

Run by

Hernán Darío Castro Arias

People needed

30

Starts

2026-05-27

Expected to finish

2027-03-01

Last updated by the study team

2026-07-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• - 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

You may not qualify if…

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

Where it is running

• Clinica Medellin Sede Occidente — Medellín, Antioquia, Colombia (enrolling)

Full record on ClinicalTrials.gov

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