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Recruiting NCT07683299

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

— Observational Cardiac Surgery Cardiopulmonary Bypass Hemodynamic Monitoring Ventricular-Arterial Coupling

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Cardiac Surgery, Cardiopulmonary Bypass, Hemodynamic Monitoring, Ventricular-Arterial Coupling. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Colombia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

HEMO-INTEGRA: Feasibility and Description of an Integrated Intraoperative Hemodynamic Monitoring System for Cardiac Surgery With Cardiopulmonary Bypass - A Pilot Observational Study

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.

Primary outcome measures

  • Data Capture Completeness [Time frame: Intraoperative (0 to 6 hours)]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Colombia · 1 center
  • Clinica Medellin Sede Occidente — Medellín

Identifiers

NCT: NCT07683299 · HI-PILOT-2026-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗