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Ischemic Heart DiseaseNCT00641290

Vigileo FloTrac vs Pulmonary Artery Catheter

An observational study of Ischemic Heart Disease and Valvular Heart Disease, run by Hospital Sultanah Aminah Johor Bahru at 1 site in Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Any age
What is being tested?
Vigileo FloTrac Sensor
Type of treatment
Medical device
How many people
60 participants
Where
1 siteMalaysia
Study dates
Apr 2008to Aug 2008
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Gunalan P Arumugam, MBBS contact

0060122057474

gunalan73@yahoo.com

Malaysia1 site
  • Hospital Sultanah Aminah

    Johor Bahru, Johor, 80100

    Gunalan P Arumugam, MBBS

    Raha M. Daud, MD

Other trials in Malaysia

About this study

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

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.

Read the 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.

Being tested
Vigileo FloTrac Sensor
Keywords
CABG, Valve surgery
Medical subject headings
Myocardial Ischemia, Heart Valve Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Vigileo FloTrac SensorDevice

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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cardiac output and other haemodynamic indices

    Measured: 48 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Mar 2008 (estimated)
  2. Study startApr 2008
  3. Primary completionAug 2008 (estimated)
  4. Study completionAug 2008 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00641290
Sponsor's protocol ID
NMRR ID 08-645-1800
Status last verified
Apr 2008
First submitted
17 Mar 2008
Last updated
15 Apr 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Ischemic Heart Disease and Valvular Heart Disease, run by Hospital Sultanah Aminah Johor Bahru at 1 site in Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Gunalan P Arumugam, MBBS (0060122057474, gunalan73@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cardiac output and other haemodynamic indices (time frame: 48 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2008.

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