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CompletedNCT00464750Updated Jul 18, 2016

Study on the Repeatability of Cardiac Output Measurements Dependence of Temperature of Injectate

An observational study in Heart Diseases, sponsored by Norwegian University of Science and Technology. Completed at 1 site in Norway. Open to participants aged 18 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-07-18.

Sponsored by Norwegian University of Science and Technology · Observational

Study type
Observational
Time perspective
Prospective
Enrollment
40
Ages
18 Years to 85 Years
Sex
All
01

Study summary

This study tests the reliability of thermodilution cardiac output measurements with pulmonary artery catheters in immediate connection with heart surgery. In accordance with our clinical practice, thermal indicator injections are synchronized with respiration. The impact on measurement repeatability of spontaneous vs artificial ventilation and the effect of the injectate temperature is tested.

The study hypothesis is that when injections are synchronized with the respiration, only three injections at room temperature are needed to be within 5 % of the "true" cardiac output in mechanically ventilated patients.

Read the detailed description

Bolus thermodilution cardiac output measurements by means of a pulmonary artery catheter have been a mainstay of monitoring critically ill patients for more than thirty years. Recent studies have questioned wether the traditional practice of averaging measurements from tree room temperature thermal indicator injections give sufficient precision.

This study tests the number of indicator injections necessary to be within 5 % of the "true" cardiac output (taken as the average of 16 injections) when the injection is synchronized with the respiration. The reliability of the thermodilution measurements are tested A) in sedated, artificially ventilated cardiac surgical patients and B) in the same patients when postoperatively awake and spontaneously breathing. We further compare the use of room temperature and iced thermal indicator injections.

The study hypothesis is that when injections are synchronized with the respiration, only three injections at room temperature are needed to achieve the desired precision in mechanically ventilated patients.

Only patients receiving a pulmonary artery catheter according our institution standard procedure of care will be included.

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Conditions studied

  • Heart Diseases

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Keywords

  • Cardiac output
  • Thermodilution
03

In context

Heart Diseases

3,639 studies on the registry are indexed under Heart Diseases; 461 are open to participants now.

This study's enrollment of 40 is below the median of 294 across 1,241 observational studies indexed under Heart Diseases.

Browse Heart Diseases studies →

Lead sponsor

Norwegian University of Science and Technology is the lead sponsor of 487 studies on the registry; 52 are open to participants now.

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

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Who can participate

Ages eligible
18 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Elective patients for cardiac surgery

Inclusion criteria

  • Cardiac surgical patients who receive a pulmonary artery catheter according to the institution clinical criteria -

Exclusion criteria

Exclusion Criteria:

  • Acute cardiac surgery
  • Preoperative arrythmias
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Study design

Time perspective
Prospective
Enrollment
40 participants (actual)

Interventions

  • DevicePulmonary artery catheter

    Four series of cardiac output measurements, each series consists of eight measurements using cold and eight measurements using tepid injectate. Randomized order of temperature at first series and crossover design.

    Also known as: Baxter

06

Study locations

1 site
  • St Olav University Hospital
    Trondheim, Norway
07

References and documents

Publications

  • Kirkeby-Garstad I, Tronnes H, Stenseth R, Sellevold OF, Aadahl P, Skogvoll E. The Precision of Pulmonary Artery Catheter Bolus Thermodilution Cardiac Output Measurements Varies With the Clinical Situation. J Cardiothorac Vasc Anesth. 2015 Aug;29(4):881-8. doi: 10.1053/j.jvca.2014.12.016. Epub 2014 Dec 12. Erratum In: J Cardiothorac Vasc Anesth. 2016 Jan;30(1):273. PubMed 25976600 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 18, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00464750
Lead sponsor
Norwegian University of Science and Technology
Responsible party
Sponsor
First posted
Apr 24, 2007
Start date
Nov 2006
Completion
Jun 2007
Last update
Jul 18, 2016

Study contacts

Idar Kirkeby-Garstad, MD, Ph D
principal investigator · St. Olav University Hospital, Trondheim, Norway

Oversight

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

Not currently enrolling

This study is completed, as verified in Jul 2016. You cannot join it, but the record below documents what was studied.

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