Vigileo FloTrac vs Pulmonary Artery Catheter

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2008 by Hospital Sultanah Aminah Johor Bahru.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Hospital Sultanah Aminah Johor Bahru
ClinicalTrials.gov Identifier:
NCT00641290
First received: March 17, 2008
Last updated: April 4, 2008
Last verified: April 2008
  Purpose

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.


Condition Intervention
Ischemic Heart Disease
Valvular Heart Disease
Device: Vigileo FloTrac Sensor

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Hospital Sultanah Aminah Johor Bahru:

Primary Outcome Measures:
  • Cardiac output and other haemodynamic indices [ Time Frame: 48 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: April 2008
Estimated Study Completion Date: August 2008
Estimated Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Vigileo FloTrac Sensor
    Comparing the Vigileo FloTrac against the conventional Pulmonary Artery Catheter using the thermodilution method for measurements of cardiac output.
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641290

Contacts
Contact: Gunalan P Arumugam, MBBS 0060122057474 gunalan73@yahoo.com

Locations
Malaysia
Hospital Sultanah Aminah Not yet recruiting
Johor Bahru, Johor, Malaysia, 80100
Principal Investigator: Gunalan P Arumugam, MBBS         
Sub-Investigator: Raha M. Daud, MD         
Sub-Investigator: Zanariah Sabiron, MD         
Sub-Investigator: Salamah Azerai, MD         
Sub-Investigator: Subrahmanyam Balan, MBBS         
Sponsors and Collaborators
Hospital Sultanah Aminah Johor Bahru
Investigators
Study Chair: Subrahmanyam Balan, MBBS Hospital Sultanah Aminah Johor Bahru
  More Information

No publications provided

Responsible Party: Dr. Gunalan Palari Arumugam, Hospital Sultanah Aminah Johor Bahru
ClinicalTrials.gov Identifier: NCT00641290     History of Changes
Other Study ID Numbers: NMRR ID 08-645-1800
Study First Received: March 17, 2008
Last Updated: April 4, 2008
Health Authority: Malaysia: Ministry of Health

Keywords provided by Hospital Sultanah Aminah Johor Bahru:
CABG
Valve surgery

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Heart Valve Diseases
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on August 27, 2014