Study on the Repeatability of Cardiac Output Measurements Dependence of Temperature of Injectate
|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.|
|ClinicalTrials.gov Identifier: NCT00464750|
Recruitment Status : Completed
First Posted : April 24, 2007
Last Update Posted : July 18, 2016
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 or disease||Intervention/treatment|
|Heart Diseases||Device: Pulmonary artery catheter|
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.
|Study Type :||Observational|
|Actual Enrollment :||40 participants|
|Official Title:||The Impact of Temperature of the Injectate on the Precision (Repeatability) of Cardiac Output Measurements Synchronized With the Respiration (the Temperature Study)|
|Study Start Date :||November 2006|
|Actual Study Completion Date :||June 2007|
Device: Pulmonary artery catheter
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
|St Olav University Hospital|
|Principal Investigator:||Idar Kirkeby-Garstad, MD, Ph D||St Olav University Hospital, Trondheim, Norway|