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Status unknownNCT01773720Updated Jan 23, 2013

Reliability of Cardiac Output Monitoring Based on Uncalibrated Pulse Contour Analysis

An observational study in Cardiac Index, sponsored by Northern State Medical University. Status unknown at 1 site in Russian Federation. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2013-01-23.

Sponsored by Northern State Medical University · Observational

The sponsor has not verified this record recently (last verified Jan 2013), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Cardiac Index

Keywords

  • cardiac index
  • coronary artery bypass
  • uncalibrated pulse contour analysis
  • hemodynamic monitoring
03

In context

Lead sponsor

Northern State Medical University is the lead sponsor of 23 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
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

Inclusion criteria

  • elective off-pump coronary artery bypass grafting

Exclusion criteria

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.
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No
Biospecimen retention
None retained
06

What researchers measure

Primary outcomes

  1. Validity of cardiac index measurement

    Accuracy and precision of cardiac index measurement using uncalibrated pulse contour analysis in comparison with transpulmonary thermodilution

    Time frame: Up to 24 hrs post surgery

07

Study locations

1 of 1 sites recruiting
  • Dep. of Anesthesiology, Northern SMU
    Arkhangelsk, 163000, Russian Federation
    • Mikhail Y Kirov, MD, PhD · Contact · mikhail_kirov@hotmail.com · +7-8182-63-27-30
    • Alexey A Smetkin, MD · Principal 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 · Sub investigator
    Recruiting
08

References and documents

Publications

  • Smetkin AA, Hussain A, Kuzkov VV, Bjertnaes LJ, Kirov MY. Validation of cardiac output monitoring based on uncalibrated pulse contour analysis vs transpulmonary thermodilution during off-pump coronary artery bypass grafting. Br J Anaesth. 2014 Jun;112(6):1024-31. doi: 10.1093/bja/aet489. Epub 2014 Feb 13. PubMed 24531685 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 23, 2013, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01773720
Lead sponsor
Northern State Medical University
Responsible party
Sponsor
First posted
Jan 23, 2013
Start date
Oct 2011
Primary completion
Mar 2013 (estimated)
Completion
Mar 2013 (estimated)
Last update
Jan 23, 2013

Study contacts

Mikhail Y Kirov, MD, PhD
Contact
mikhail_kirov@hotmail.com
+7-8182-63-27-30
Mikhail Y Kirov, MD, PhD
study director · Northern State Medical Univercity

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2013. You cannot join it, but the record below documents what was studied.

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