Manual- VS Auto-Strain

Automated Measurements of Left Ventricular Longitudinal Strain: Are the Results Comparable to Manual Measurements During Cardiac Surgery?

Myocardial strain analysis provides additional and valuable information about left ventricular function, particularly in the perioperative setting with its dynamic changes in ventricular load conditions. This allows for earlier risk assessment and, if necessary, the initiation of faster and more targeted therapy. Unfortunately, conventional strain analysis using conventional methods currently takes approximately 5 minutes. However, this amount of time is often not available in a dynamically changing intraoperative setting during cardiac surgery. Therefore, the benefits of strain analysis have not yet been routinely utilized during the intraoperative course. However, new software solutions exist that can perform strain analysis fully automatically and reduce the examination time to a few seconds. However, it remains unclear whether these fully automated analyses also function reliably intraoperatively using transesophageal echocardiography (TEE). The aim of this study is to assess the reliability of these new methods.

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery Patients; Transesophageal Echocardiography; Cardiac Anesthesia

• Study Type: Observational
• Enrollment (Estimated): 70

Contacts and Locations

• Study Contact: Name: Bruno Mora, Dr, MD, PhD; Phone Number: +4314040041090; Email: bruno.mora@meduniwien.ac.at

Study Locations

• Austria
  • Vienna, Austria, 1090
    • Recruiting
    • General Hospital of Vienna - Medical University of Vienna
    • Contact: Bruno Mora, Dr, MD, PhD; Phone Number: +4314040041090; Email: bruno.mora@meduniwien.ac.at

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients undergoing cardiac surgery who are monitored with a transesophageal echocardiography probe

Description

Inclusion Criteria:

• Adult (≥18 years) cardiac surgery patients
• Sinus rhythm
• No severe valvular regurgitation
• Use of General Electric (GE) echocardiography systems (Vivid S60, S70, E95) and corresponding EchoPAC software as well as TOMTEC software.

Exclusion Criteria:

• Inadequate image quality
• Any severe heart valve regurgitation
• Mechanical circulatory support systems (e.g., LVAD, Impella, ECMO)

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Correlation between conventionally measured global longitudinal strain (GLS) and fully automated global longitudinal strain (Auto-GLS)	1-3 days

Secondary Outcome Measures

Outcome Measure	Time Frame
Correlation between fully automated global longitudinal strain measured using GE EchoPac (GE-Auto-GLS) and fully automated global longitudinal strain measured using TOMTEC AutoStrain (TOMTEC Auto-GLS)	1 day

Collaborators and Investigators

• Sponsor: Bruno Mora

Study record dates

Study Major Dates

• Study Start (Estimated): March 23, 2026
• Primary Completion (Estimated): March 23, 2027
• Study Completion (Estimated): March 23, 2027

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: March 22, 2026
• First Posted (Actual): March 27, 2026

Study Record Updates

• Last Update Posted (Actual): March 27, 2026
• Last Update Submitted That Met QC Criteria: March 22, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: MUV EK 2416/2025

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No