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NCT01611376 Clinical Trial

Impedance Cardiography During Major Abdominal Surgery

Abdominal Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01611376
Other study ID # ICG-01-Choe
Secondary ID
Status Completed
Phase Phase 4
First received May 31, 2012
Last updated August 16, 2013
Start date September 2012
Est. completion date February 2013

Study information
Verified date May 2012
Source Inje University
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 11
Est. completion date February 2013
Est. primary completion date January 2013
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 80 Years
Eligibility Inclusion Criteria:

- Patients undergoing open gastrectomy with arterial line

- ASA 1 & 2

Exclusion Criteria:

- severe valve disease

- severe lung disease

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Device:
• Niccomo™ (Medis, Ilmenau, Germany) impedance cardiography

Locations
Country Name City State
Korea, Republic of Ilsan Paik hospital Goyang-si Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Inje University

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (1)

Kim JY, Kim BR, Lee KH, Kim KW, Kim JH, Lee SI, Kim KT, Choe WJ, Park JS, Kim JW. Comparison of cardiac output derived from FloTrac™/Vigileo™ and impedance cardiography during major abdominal surgery. J Int Med Res. 2013 Aug;41(4):1342-9. doi: 10.1177/030 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Cardiac output Cardiac output will be measured using an ICG and compared with cardiac output measured using Flotrac/vigileo No
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