Evaluation of Clinical Utility of Non-invasive Hemodynamic Monitoring Device

Cardiovascular Complication Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05996965
• Other study ID #: HemoVista
• Status: Recruiting
• Start date: November 21, 2023
• Est. completion date: December 30, 2024

Study information

• Verified date: November 2023
• Source: Seoul National University Hospital
• Contact: Hee-Soo Kim
• Phone: +82220723659
• Email: dami0605[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: December 30, 2024
• Est. primary completion date: December 10, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Complication

Intervention

Other:
• HemoVista
additional attatchment of non-invasive hemodynamic monitoring HemoVista with FloTrac

Locations

Country	Name	City	State
Korea, Republic of	Hee-Soo Kim	Seoul	Soul-t'ukpyolsi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	degree of agreement in cardiac output	degree of agreement in cardiac output between HemoVista and FloTrac	during surgery