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.
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
- Conditions the study is for
- Ischemic Heart Disease, Valvular Heart Disease
- 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.
Malaysia1 site
Hospital Sultanah Aminah
Johor Bahru, Johor, 80100
Gunalan P Arumugam, MBBS
Raha M. Daud, MD
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.
- Conditions
- Ischemic Heart Disease, Valvular Heart Disease
- 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.
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.
- First posted24 Mar 2008 (estimated)
- Study startApr 2008
- Primary completionAug 2008 (estimated)
- Study completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Hospital Sultanah Aminah Johor Bahru
- Sponsor type
- Other government
- Investigators
- Subrahmanyam Balan, MBBS, Study chair, Hospital Sultanah Aminah Johor Bahru
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00641290
- Acronym / sponsor ID
- NMRR ID 08-645-1800
- Conditions
- Ischemic Heart Disease, Valvular Heart Disease
- Keywords
- CABG, Valve surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospital Sultanah Aminah Johor BahruOther government
- Study start
- Apr 2008
- Primary completion
- Aug 2008 (estimated)
- Study completion
- Aug 2008 (estimated)
- First posted
- 24 Mar 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who are undergoing coronary bypass graft surgery and valvular heart disease.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vigileo FloTrac SensorComparing the Vigileo FloTrac against the conventional Pulmonary Artery Catheter using the thermodilution method for measurements of cardiac output. | Device | – |
Primary outcome
Cardiac output and other haemodynamic indices
Time frame: 48 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2008.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Subrahmanyam Balan, MBBS study chair
Hospital Sultanah Aminah Johor Bahru
1 site in 1 country: see every site and its status.
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.