NCT00464750

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2006

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 24, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

July 18, 2016

Status Verified

July 1, 2016

First QC Date

April 23, 2007

Last Update Submit

July 15, 2016

Conditions

Heart Diseases

Keywords

Cardiac outputThermodilution

Interventions

Pulmonary artery catheterDEVICE

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

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Elective patients for cardiac surgery

You may qualify if:

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

You may not qualify if:

  • Acute cardiac surgery
  • Preoperative arrythmias

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olav University Hospital

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 25976600RESULT

MeSH Terms

Conditions

Heart Diseases

Condition Hierarchy (Ancestors)

Cardiovascular Diseases

Study Officials

  • Idar Kirkeby-Garstad, MD, Ph D

    St. Olav University Hospital, Trondheim, Norway

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2007

First Posted

April 24, 2007

Study Start

November 1, 2006

Study Completion

June 1, 2007

Last Updated

July 18, 2016

Record last verified: 2016-07

Locations

NO(1)