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Reliability of Cardiac Output Monitoring Based on Uncalibrated Pulse Contour Analysis

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ClinicalTrials.gov Identifier: NCT01773720
Recruitment Status : Unknown
Verified January 2013 by Northern State Medical University.
Recruitment status was:  Recruiting
First Posted : January 23, 2013
Last Update Posted : January 23, 2013
Sponsor:
Information provided by (Responsible Party):
Northern State Medical University

Brief Summary:
The aim of our study was to evaluate the reliability of uncalibrated cardiac index monitoring based on arterial waveform analysis in patients undergoing off-pump coronary artery bypass grafting.

Condition or disease
Cardiac Index

Detailed Description:
Using contemporary statistical method the cardiac index values obtained via uncalibrated pulse contour analysis with Pro AQT system will be compared with traditional transpulmonary thermodilution technique (Pulsion, Germany).

Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Evaluation of Reliability of Cardiac Output Monitoring Based on Uncalibrated Pulse Contour Analysis During Off-pump Coronary Artery Bypass Grafting
Study Start Date : October 2011
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. Validity of cardiac index measurement [ Time Frame: Up to 24 hrs post surgery ]
    Accuracy and precision of cardiac index measurement using uncalibrated pulse contour analysis in comparison with transpulmonary thermodilution


Biospecimen Retention:   None Retained
No biospecimens are to be retained.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with coronary artery disease, ranked ASA II-III and scheduled for elective off-pump coronary artery bypass grafting
Criteria

Inclusion Criteria:

  • elective off-pump coronary artery bypass grafting

Exclusion Criteria:

  • age < 18 and > 80 years,
  • preoperative ejection fraction < 0.35,
  • severe cardiac valve dysfunction or peripheral vascular disease,
  • constant atrial fibrillation,
  • simultaneous interventions (carotid endarterectomy, aneurysm repair, etc.),
  • transfer to cardiopulmonary bypass.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01773720


Contacts
Contact: Mikhail Y Kirov, MD, PhD +7-8182-63-27-30 mikhail_kirov@hotmail.com

Locations
Russian Federation
Dep. of Anesthesiology, Northern SMU Recruiting
Arkhangelsk, Russian Federation, 163000
Contact: Mikhail Y Kirov, MD, PhD    +7-8182-63-27-30    mikhail_kirov@hotmail.com   
Principal Investigator: Alexey A Smetkin, MD         
Sub-Investigator: Mikhail Y Kirov, MD, PhD         
Sub-Investigator: Ayyaz Hussain, MD         
Sub-Investigator: Vsevolod V Kuzkov, MD, PhD         
Sub-Investigator: Lars J Bjertnæs, MD, PhD         
Sponsors and Collaborators
Northern State Medical University
Investigators
Study Director: Mikhail Y Kirov, MD, PhD Northern State Medical Univercity

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Northern State Medical University
ClinicalTrials.gov Identifier: NCT01773720     History of Changes
Other Study ID Numbers: UncalPCA-vs-TPTD
First Posted: January 23, 2013    Key Record Dates
Last Update Posted: January 23, 2013
Last Verified: January 2013

Keywords provided by Northern State Medical University:
cardiac index
coronary artery bypass
uncalibrated pulse contour analysis
hemodynamic monitoring