Evaluation of Clinical Utility of Non-invasive Hemodynamic Monitoring Device

Sponsor
Seoul National University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05996965
Collaborator
(none)
40
16

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Anticipated Enrollment :
40 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Evaluation of Clinical Utility of Non-invasive Hemodynamic Monitoring Device (HemoVista™) in the Clinical Filed
Anticipated Study Start Date :
Aug 30, 2023
Anticipated Primary Completion Date :
Dec 10, 2024
Anticipated Study Completion Date :
Dec 30, 2024

Outcome Measures

Primary Outcome Measures

  1. degree of agreement in cardiac output [during surgery]

    degree of agreement in cardiac output between HemoVista and FloTrac

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Seoul National University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Hee-Soo Kim, professor, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT05996965
Other Study ID Numbers:
  • HemoVista
First Posted:
Aug 18, 2023
Last Update Posted:
Aug 21, 2023
Last Verified:
Aug 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Aug 21, 2023