NCT05996965

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 10, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 18, 2023

Completed
3 months until next milestone

Study Start

First participant enrolled

November 21, 2023

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2024

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

November 22, 2023

Status Verified

November 1, 2023

Enrollment Period

1.1 years

First QC Date

August 10, 2023

Last Update Submit

November 20, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • degree of agreement in cardiac output

    degree of agreement in cardiac output between HemoVista and FloTrac

    during surgery

Interventions

additional attatchment of non-invasive hemodynamic monitoring HemoVista with FloTrac

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients aged 20 or older

You may qualify if:

  • 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

You may not qualify if:

  • problems in site where HemoVista is attached

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hee-Soo Kim

Seoul, Soul-t'ukpyolsi, 03080, South Korea

RECRUITING

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

August 10, 2023

First Posted

August 18, 2023

Study Start

November 21, 2023

Primary Completion

December 10, 2024

Study Completion

December 30, 2024

Last Updated

November 22, 2023

Record last verified: 2023-11

Locations