Evaluation of Clinical Utility of Non-invasive Hemodynamic Monitoring Device

Evaluation of Clinical Utility of Non-invasive Hemodynamic Monitoring Device (HemoVista™) in the Clinical Filed

In patients undergoing surgery under general anesthesia, the clinical utility of non-invasive hemodynamic status monitoring equipment using HemoVista is compared with invasive hemodynamic status monitoring equipment FloTrac.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Complication
• Intervention / Treatment: Other: HemoVista

Detailed Description

For patients who are scheduled to monitor invasive blood pressure, invasive hemodynamic monitoring using FloTrac and additional HemoVista sensors are attached and output data are obtained at the same time during general anesthesia. FloTrac is used to conduct conventional anesthesia and fluid therapy, and the accuracy of HemoVista, a non-invasive hemodynamic monitoring equipment, is compared through prospective observational studies.

• Study Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Hee-Soo Kim; Phone Number: +82220723659; Email: dami0605@snu.ac.kr

Study Locations

• Korea, Republic of
  • Soul-t'ukpyolsi
    • Seoul, Soul-t'ukpyolsi, Korea, Republic of, 03080
      • Recruiting
      • Hee-Soo Kim
      • Contact: Eun-Hee Kim, MD.; Phone Number: 08201099335014; Email: beloveun@gmail.com
      • Contact: Hee-Soo Kim, MD.PhD; Phone Number: 08201052878006; Email: dami0605@snu.ac.kr

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

Adult patients aged 20 or older

Description

Inclusion Criteria:

• Adult patients aged 20 or older who undergo surgery under general anesthesia for more than two hours
• invasive close hemodynamic monitoring with FloTrac is needed

Exclusion Criteria:

• problems in site where HemoVista is attached

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
degree of agreement in cardiac output	degree of agreement in cardiac output between HemoVista and FloTrac	during surgery

Collaborators and Investigators

• Sponsor: Seoul National University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): November 21, 2023
• Primary Completion (Estimated): December 10, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: August 10, 2023
• First Submitted That Met QC Criteria: August 10, 2023
• First Posted (Actual): August 18, 2023

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: HemoVista

Drug and device information, study documents

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