Reliability of Cardiac Output Monitoring Based on Uncalibrated Pulse Contour Analysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Northern State Medical University
Sponsor:
Information provided by (Responsible Party):
Northern State Medical University
ClinicalTrials.gov Identifier:
NCT01773720
First received: January 15, 2013
Last updated: January 18, 2013
Last verified: January 2013
  Purpose

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
Cardiac Index

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Northern State Medical University:

Primary Outcome Measures:
  • Validity of cardiac index measurement [ Time Frame: Up to 24 hrs post surgery ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 40
Study Start Date: October 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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.
  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: 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
  More Information

No publications provided by Northern State Medical University

Additional 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
Study First Received: January 15, 2013
Last Updated: January 18, 2013
Health Authority: Russia: Ministry of Health of the Russian Federation

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

ClinicalTrials.gov processed this record on September 30, 2014