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

NCT07683299 | Recruiting

• 1 other identifier: HI-PILOT-2026-001
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiac Surgery; Cardiopulmonary Bypass; Hemodynamic Monitoring; Ventricular-Arterial Coupling

Keywords

HEMO-INTEGRA; VExUS; Oxygen Delivery; NIRS; Deep Hypothermia; Transesophageal Echocardiography; Clinical Decision Support

Outcome Measures

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.

  Intraoperative (0 to 6 hours)

Study Arms (1)

HEMO-INTEGRA Cohort

Adult patients undergoing elective cardiac surgery with cardiopulmonary bypass monitored with the HEMO-INTEGRA integrated hemodynamic monitoring system across five intraoperative time points (T0 to T4). Intervention Name : HEMO-INTEGRA v2.0 Software system for integrated intraoperative hemodynamic monitoring integrating ventricular-arterial coupling (Balan 2026), tissue perfusion (EPOC/Q10), neuromonitoring (NIRS/BIS), and venous congestion (VExUS-TEE). Operates in parallel with standard care without modifying clinical management.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

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

Sponsors & Collaborators

• Hernán Darío Castro Arias: lead

Study Sites (1)

Clinica Medellin Sede Occidente

Medellín, Antioquia, Colombia

RECRUITING

Study Officials

• Hernan D Castro-Arias, MD MSc

  Clinica Medellin Sede Occidente, Grupo Quiron Salud

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hernan D Castro-Arias, MD MSc

CONTACT

+573128633884; hernan_castro@icloud.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Cardiac Anesthesiologist and Principal Investigator

Study Record Dates

• First Submitted: June 27, 2026
• First Posted: July 6, 2026
• Study Start: May 27, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): March 1, 2027
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

CO (1)