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

This trial does not accept healthy volunteers

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 population

Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass at Clinica Medellin Sede Occidente, Medellin, Colombia.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

30 Participants
are grouped into 1 trial group
Group A: HEMO-INTEGRA Cohort

Trial outcomes

Primary outcomes

1

Data Capture Completeness

Proportion of cases with complete data capture across all five intraoperative time points (T0 to T4) for all four HEMO-INTEGRA monitoring modules: ventricular-arterial coupling, tissue perfusion, neuromonitoring, and venous congestion assessment.

Time frame
Intraoperative (0 to 6 hours)

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hernán Darío Castro Arias

Lead sponsor

Hernán Darío Castro Arias MD MSc

Sponsor institution