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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00464750
First Posted: April 24, 2007
Last Update Posted: July 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Norwegian University of Science and Technology
  Purpose

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.


Condition Intervention Phase
Heart Diseases Device: Pulmonary artery catheter Early Phase 1

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: The Impact of Temperature of the Injectate on the Precision (Repeatability) of Cardiac Output Measurements Synchronized With the Respiration (the Temperature Study)

Further study details as provided by Norwegian University of Science and Technology:

Enrollment: 40
Study Start Date: November 2006
Study Completion Date: June 2007
Intervention Details:
    Device: Pulmonary 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.
    Other Name: Baxter
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Elective patients for cardiac surgery
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Acute cardiac surgery
  • Preoperative arrythmias
  Contacts and Locations
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): NCT00464750


Locations
Norway
St Olav University Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
Investigators
Principal Investigator: Idar Kirkeby-Garstad, MD, Ph D St Olav University Hospital, Trondheim, Norway
  More Information

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00464750     History of Changes
Other Study ID Numbers: 4.2006.1012 / NSD15499
First Submitted: April 23, 2007
First Posted: April 24, 2007
Last Update Posted: July 18, 2016
Last Verified: July 2016

Keywords provided by Norwegian University of Science and Technology:
Cardiac output
Thermodilution

Additional relevant MeSH terms:
Heart Diseases
Cardiovascular Diseases