Study on the Repeatability of Cardiac Output Measurements Dependence of Temperature of Injectate
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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 |
|---|---|---|
|
Thermodilution, Cardiac Output |
Device: Pulmonary artery catheter |
Phase 0 |
| 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) |
| Enrollment: | 40 |
| Study Start Date: | November 2006 |
| Study Completion Date: | June 2007 |
-
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.
Eligibility| Ages Eligible for Study: | 18 Years to 85 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Elective patients for cardiac surgery
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| Norway | |
| St Olav University Hospital | |
| Trondheim, Norway | |
| Principal Investigator: | Idar Kirkeby-Garstad, MD, Ph D | St Olav University Hospital, Trondheim, Norway |
More Information
Publications:
| Responsible Party: | Asbjorn Karevold, Head of Department, Dept of Cardiothoracic surgery, St Olav Univ Hospital, Trondheim, Norway |
| ClinicalTrials.gov Identifier: | NCT00464750 History of Changes |
| Other Study ID Numbers: | 4.2006.1012 / NSD15499 |
| Study First Received: | April 23, 2007 |
| Last Updated: | May 28, 2008 |
| Health Authority: | Norway: Norwegian Social Science Data Services |
ClinicalTrials.gov processed this record on May 19, 2013