Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage
Recruitment status was Recruiting
This study will evaluate the accuracy of two rapid methods of measuring hemoglobin in patients with suspected hemorrhage. These methods will be compared with standard laboratory measurements.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Non-Invasive Hemoglobin Monitoring in the Patient With Suspected Hemorrhage|
- Accuracy of invasive, point-of-care hemoglobin measurements [ Time Frame: Whenever serial blood draws for standard hemoglobin measurements take place. Typically this is at least once per day. Tracking will continue until ICU Day 7. ] [ Designated as safety issue: No ]Whenever blood is drawn for laboratory measurement of serum hemoglobin, we will also use one drop of blood to make a point-of-care measurement using the iSTAT technology.
|Study Start Date:||September 2012|
|Estimated Study Completion Date:||December 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Patients with Suspected Hemorrhage
There is a single group of patients in this study -- those with suspected hemorrhage who satisfy the inclusion and exclusion criteria. The same set of measurements will be take from each patients and those measurements will be compared with one another to determine accuracy.
Anemia and bleeding are major causes of morbidity and mortality in both surgical and nonsurgical patients. The current standard of care for monitoring patients at risk for bleeding is serial measurement of hemoglobin levels. At present, the photometric cyanmethemoglobin method is the most widely used technique for monitoring hemoglobin in the lab, and is currently the gold standard. However, this method has potential for delay before final results are obtained.
Immediate hemoglobin measurements are available with portable point-of-care devices such as the iSTAT, which can produce a measurement of hemoglobin concentration in less than 1 minute. Unfortunately, the accuracy of this device has been reported to vary with hemoglobin level, and as such may not be as accurate in detecting blood loss when compared with the gold standard of laboratory analysis.
Recently, a noninvasive, spectrophotometry-based monitoring technology has been developed. This novel technology measures the differential optical density of wavelengths of light passed through the finger in a method similar to conventional pulse oximetry. While some studies have reported that this device appears to be accurate in patients undergoing elective surgical procedures, more recent work suggests that this accuracy degrades with increased blood loss, lower oximeter signal quality and lower absolute Hgb values.
We will evaluate the accuracy of point-of-care and non-invasive SpHb measurements and utility of continuous hemoglobin monitoring in an intensive care unit setting. If these methods of rapid hemoglobin measurement can be validated in patients at risk for ongoing hemorrhage, use of this technology may result in earlier detection of ongoing hemorrhage, expedite appropriate treatment, and improve patient outcomes.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01709786
|Contact: Betty J Tsuei, MDfirstname.lastname@example.org|
|Contact: Richard D Branson, MScemail@example.com|
|United States, Ohio|
|Cincinnati, Ohio, United States, 45219|
|Contact: Betty J Tsuei, MD 513-558-5661 firstname.lastname@example.org|