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

The Impact of Temperature of the Injectate on the Precision (Repeatability) of Cardiac Output Measurements Synchronized With the Respiration (the Temperature Study)

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00464750
Enrollment
40
Registered
2007-04-24
Start date
2006-11-30
Completion date
2007-06-30
Last updated
2016-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Heart Diseases

Keywords

Cardiac output, Thermodilution

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.

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.

Interventions

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.

Sponsors

Norwegian University of Science and Technology
Lead SponsorOTHER

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* Acute cardiac surgery * Preoperative arrythmias

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026