NCT00641290

Brief Summary

To study the role of Vigileo monitor using the FloTrac sensor to measure cardiac output using the pulse contour analysis as well as central venous oxygen saturation monitoring as a guide for tissue perfusion. The accuracy of the Vigileo monitoring was compared with the conventional thermodilution method for measuring cardiac output using the pulmonary artery catheter and mixed venous oxygen saturation for assessing global tissue perfusion.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2008

Shorter than P25 for all trials

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 17, 2008

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2008

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
Last Updated

April 15, 2008

Status Verified

April 1, 2008

Enrollment Period

4 months

First QC Date

March 17, 2008

Last Update Submit

April 4, 2008

Conditions

Ischemic Heart DiseaseValvular Heart Disease

Keywords

CABGValve surgery

Outcome Measures

Primary Outcomes (1)

  • Cardiac output and other haemodynamic indices

    48 hours

Interventions

Vigileo FloTrac SensorDEVICE

Comparing the Vigileo FloTrac against the conventional Pulmonary Artery Catheter using the thermodilution method for measurements of cardiac output.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All patients who are undergoing coronary bypass graft surgery and valvular heart disease.

You may not qualify if:

  • Patients will be excluded if they are on Intra Aortic Balloon Pump (IABP), requiring emergency chest reopening, significant arrhythmia which causes an irregular arterial waveform and tricuspid regurgitation as ruled out during the pre operative echocardiogram.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sultanah Aminah

Johor Bahru, Johor, 80100, Malaysia

Location

MeSH Terms

Conditions

Myocardial IschemiaHeart Valve Diseases

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Subrahmanyam Balan, MBBS

    Hospital Sultanah Aminah Johor Bahru

    STUDY CHAIR

Central Study Contacts

Gunalan P Arumugam, MBBS

CONTACT

0060122057474gunalan73@yahoo.com

Study Design

Study Type
observational
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

March 17, 2008

First Posted

March 24, 2008

Study Start

April 1, 2008

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

April 15, 2008

Record last verified: 2008-04

Locations

MY(1)