Impedance Cardiography During Major Abdominal Surgery

August 16, 2013 updated by: Inje University

Comparison of Cardiac Output Derived From Flotrac/Vigileo and Impedance Cardiography During Major Abdominal Surgery

The investigators validated ICG's(impedance cardiography) usefulness during the abdominal surgery, by comparing it with FloTrac/Vigileo™ (Edwards Lifesciences,Irvine, CA, USA)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Intrathoracic structures have relatively constant resistance except the influence of changing diameter of aorta. Great vessels in thorax has the lowest resistance, and their diameter changes by the beats of the heart. As their diameter increases, their resistance decreases. ICG measures the difference between the resistances caused by heartbeats, and calculates cardiac output.

But during the surgery, there are many interfering electrical currents made by electro cautery, patient positioning, and internal organ handling. Therefore, it has been thought that ICG is not a valid tool for measuring cardiac output during the surgery.

The investigators validated ICG's usefulness during the surgery, by comparing it with Floctac/Vigileo.

Study Type

Interventional

Enrollment (Actual)

11

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 411-706
        • Ilsan Paik Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing open gastrectomy with arterial line
  • ASA 1 & 2

Exclusion Criteria:

  • severe valve disease
  • severe lung disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Cardiac output
Cardiac output will be measured using an ICG and compared with cardiac output measured using Flotrac/vigileo

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inje University

Investigators

  • Study Chair: Won Joo Choe, Ilsan-Paik Hospital
  • Study Director: Jun Hyun Kim, Ilsan-Paik Hospital
  • Principal Investigator: Kyung woo Kim, Ilsan-Paik Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2012

Primary Completion (ACTUAL)

January 1, 2013

Study Completion (ACTUAL)

February 1, 2013

Study Registration Dates

First Submitted

May 31, 2012

First Submitted That Met QC Criteria

June 4, 2012

First Posted (ESTIMATE)

June 5, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

August 19, 2013

Last Update Submitted That Met QC Criteria

August 16, 2013

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • ICG-01-Choe

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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