Reliability of Cardiac Output Monitoring Based on Uncalibrated Pulse Contour Analysis

January 18, 2013 updated by: Northern State Medical University

Evaluation of Reliability of Cardiac Output Monitoring Based on Uncalibrated Pulse Contour Analysis During Off-pump Coronary Artery Bypass Grafting

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.

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Russian Federation
      • Arkhangelsk, Russian Federation, 163000
        • Recruiting
        • Dep. of Anesthesiology, Northern SMU
        • Contact:
        • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 24 hrs post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northern State Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

January 15, 2013

First Submitted That Met QC Criteria

January 18, 2013

First Posted (Estimate)

January 23, 2013

Study Record Updates

Last Update Posted (Estimate)

January 23, 2013

Last Update Submitted That Met QC Criteria

January 18, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UncalPCA-vs-TPTD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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