Evaluation of Clinical Utility of Non-invasive Hemodynami... | NCT05996965

Studies
Evaluation of Clinical Utility of Non-invasive Hemodynamic Monitoring Device

NCT05996965

Sponsor

Seoul National University Hospital

Status

Unknown status

Last Update Posted

Nov 22, 2023Actual

Enrollment

40Estimated

Phase

Not provided

Conditions

Cardiovascular Complication

Interventions

HemoVista

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 21, 2023Actual

Primary Completion Date

Dec 10, 2024Estimated

Completion Date

Dec 30, 2024Estimated

First Submitted Date

Aug 10, 2023

First Submission Date that Met QC Criteria

Aug 10, 2023

First Posted Date

Aug 18, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 20, 2023

Last Update Posted Date

Nov 22, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hee-Soo Kim, professor, Seoul National University HospitalPrincipal Investigator

Lead Sponsor

Seoul National University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

40Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
HemoVista	Other	additional attatchment of non-invasive hemodynamic monitoring HemoVista with FloTrac

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients aged 20 or older

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Hee-Soo Kim	Contact	+82220723659		dami0605@snu.ac.kr

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hee-Soo Kim	Recruiting	Seoul	Soul-t'ukpyolsi	03080	South Korea