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Vigileo FloTrac vs Pulmonary Artery Catheter

Primary Purpose

Ischemic Heart Disease, Valvular Heart Disease

Status
Unknown status
Phase
Locations
Malaysia
Study Type
Observational
Intervention
Vigileo FloTrac Sensor
Sponsored by
Hospital Sultanah Aminah Johor Bahru
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Ischemic Heart Disease focused on measuring CABG, Valve surgery

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Sites / Locations

  • Hospital Sultanah Aminah

Outcomes

Primary Outcome Measures

Cardiac output and other haemodynamic indices

Secondary Outcome Measures

Full Information

First Posted
March 17, 2008
Last Updated
April 4, 2008
Sponsor
Hospital Sultanah Aminah Johor Bahru
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1. Study Identification

Unique Protocol Identification Number
NCT00641290
Brief Title
Vigileo FloTrac vs Pulmonary Artery Catheter
Official Title
Cardiac Output and Central Venous Oxygen Saturation Monitoring Using the Vigileo FloTrac Sensor Versus Conventional Thermodilution Method Using the Pulmonary Artery Catheter: A Prospective Study
Study Type
Observational

2. Study Status

Record Verification Date
April 2008
Overall Recruitment Status
Unknown status
Study Start Date
April 2008 (undefined)
Primary Completion Date
August 2008 (Anticipated)
Study Completion Date
August 2008 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Hospital Sultanah Aminah Johor Bahru

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Cardiac Output and Central Venous Oxygen Saturation Monitoring Using the Vigileo FloTrac Sensor Versus Conventional Thermodilution Method Using the Pulmonary Artery Catheter: A Prospective Study OBJECTIVE: 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. DESIGN: A prospective clinical study conducted at the cardiothoracic operating theatre and the cardiothoracic intensive care unit of Sultanah Aminah Hospital Johor Bahru. PARTICIPANTS: 60 patients from the time of induction of anaesthesia to post operative Day 1 in the cardiothoracic intensive care unit. INTERVENTIONS: Simultaneous cardiac output measurements using the Vigileo FloTrac sensor and thermodilution method using the PAC will be obtained at the following intervals: Post Induction( T0), Pre CPB( T1), Post CPB( T2), 1 hour post ICU admission( T3), 4 hours post ICU admission( T4), 1 hour post extubation( T5) and post operative Day 1 at 0700(T6). Central venous oxygen saturation measurements and mixed venous oxygen saturation using the PAC was also obtained at similar interval times as above. Low central venous oxygen saturation is defined as less than 70% while low mixed venous oxygen saturation was fixed as less than 65% for appropriate interventions to be instituted to improve oxygen delivery. Arterial blood gases will also be done at the scheduled interval to validate whether the presence of metabolic acidosis can be used to correlate with central or mixed venous oxygen saturation measurements. MEASUREMENTS AND RESULTS: Demographic data that was recorded include age, sex, body weight, height, and body mass index, type of surgery, ejection fraction, time on cardiopulmonary bypass, Euroscore, haemoglobin and haematocrit levels. At the scheduled interval, cardiac output measurements using the thermodilution method as well as the pulse contour analysis method using the Vigileo FloTrac system will be done. Mixed venous oxygen (SvO2) will be sampled simultaneously with the central venous oxygen saturation (ScvO2 ). Demographic data will be summarized as mean ± SD where appropriate. Bland -Altman plot will be done to compare both methods for obtaining the cardiac output measurements. Linear regression analysis, Bland-Altman plot and Pearson test will be used to evaluate the correlation between SvO2 and ScvO2. A p-value of < 0.05 will be considered as significant. EXCLUSION CRITERIA: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease, Valvular Heart Disease
Keywords
CABG, Valve surgery

7. Study Design

Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Vigileo FloTrac Sensor
Intervention Description
Comparing the Vigileo FloTrac against the conventional Pulmonary Artery Catheter using the thermodilution method for measurements of cardiac output.
Primary Outcome Measure Information:
Title
Cardiac output and other haemodynamic indices
Time Frame
48 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients who are undergoing coronary bypass graft surgery and valvular heart disease. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Gunalan P Arumugam, MBBS
Phone
0060122057474
Email
gunalan73@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Subrahmanyam Balan, MBBS
Organizational Affiliation
Hospital Sultanah Aminah Johor Bahru
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Sultanah Aminah
City
Johor Bahru
State/Province
Johor
ZIP/Postal Code
80100
Country
Malaysia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gunalan P Arumugam, MBBS
First Name & Middle Initial & Last Name & Degree
Raha M. Daud, MD
First Name & Middle Initial & Last Name & Degree
Zanariah Sabiron, MD
First Name & Middle Initial & Last Name & Degree
Salamah Azerai, MD
First Name & Middle Initial & Last Name & Degree
Subrahmanyam Balan, MBBS

12. IPD Sharing Statement

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