NCT01611376

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Sep 2012

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

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

May 31, 2012

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 5, 2012

Completed
3 months until next milestone

Study Start

First participant enrolled

September 1, 2012

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2013

Completed
Last Updated

August 19, 2013

Status Verified

May 1, 2012

Enrollment Period

4 months

First QC Date

May 31, 2012

Last Update Submit

August 16, 2013

Conditions

Abdominal Surgery

Keywords

impedance cardiographyFlotrac/Vigileocardiac output

Outcome Measures

Primary Outcomes (1)

  • Cardiac output

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

Interventions

Niccomo™ (Medis, Ilmenau, Germany) impedance cardiographyDEVICE

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • severe valve disease
  • severe lung disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ilsan Paik hospital

Goyang-si, Gyeonggi-do, 411-706, South Korea

Location

Related 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: 10.1177/0300060513487649. Epub 2013 Jun 26.

    PMID: 23803309RESULT

MeSH Terms

Interventions

Cardiography, Impedance

Intervention Hierarchy (Ancestors)

Heart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosisPlethysmography, ImpedancePlethysmography

Study Officials

  • Won Joo Choe

    Ilsan-Paik Hospital

    STUDY CHAIR

  • Jun Hyun Kim

    Ilsan-Paik Hospital

    STUDY DIRECTOR

  • Kyung woo Kim

    Ilsan-Paik Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 31, 2012

First Posted

June 5, 2012

Study Start

September 1, 2012

Primary Completion

January 1, 2013

Study Completion

February 1, 2013

Last Updated

August 19, 2013

Record last verified: 2012-05

Locations

KR(1)