Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage
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| ClinicalTrials.gov Identifier: NCT01709786 |
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Recruitment Status :
Completed
First Posted : October 18, 2012
Results First Posted : August 9, 2016
Last Update Posted : August 9, 2016
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| Condition or disease |
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| Hemorrhage |
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.
| Study Type : | Observational |
| Actual Enrollment : | 88 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Non-Invasive Hemoglobin Monitoring in the Patient With Suspected Hemorrhage |
| Study Start Date : | September 2012 |
| Actual Primary Completion Date : | September 2013 |
| Actual Study Completion Date : | December 2013 |
| Group/Cohort |
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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.
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- CBC Hemoglobin Measurement Compared to Non-invasive Radical-7 Measurement [ Time Frame: n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted. ]
Whenever blood was drawn for laboratory measurement of serum hemoglobin, we used one drop of blood to make point-of-care measurements using the CDC and Radical-7 methods.
For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.
- CBC Hemoglobin Measurement Compared to Non-invasive iSTAT Measurement [ Time Frame: n ≥ 1 measurements were taken each day. All measurements (n ≥ 7) from ICU Days 1-7 were used in Bland-Altman analysis, equally weighted. ]
When blood was drawn for laboratory measurement of serum hemoglobin, one drop of blood was used to make point of care measurements using the CBC and iSTAT methods.
For purposes of reporting outcomes measures, we took an equally weighted average of measurements on each device (i.e., all measurement occasions on all patients). These are the means reported in the Outcome Measures Data Table.
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| Ages Eligible for Study: | 18 Years to 100 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- admitted to surgical intensive care unit (SICU), and
- at risk of ongoing bleeding, and
- requires serial CBC measurements
Exclusion Criteria:
- < 18 years of age, or
- a prisoner, or
- unable to have pulse oximetry readings (due to injuries, burns, amputations, or related problems)
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): NCT01709786
| United States, Ohio | |
| University Hospital | |
| Cincinnati, Ohio, United States, 45219 | |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Betty Tsuei, Professor of Surgery, University of Cincinnati |
| ClinicalTrials.gov Identifier: | NCT01709786 |
| Other Study ID Numbers: |
Tsuei-2012-06 |
| First Posted: | October 18, 2012 Key Record Dates |
| Results First Posted: | August 9, 2016 |
| Last Update Posted: | August 9, 2016 |
| Last Verified: | May 2016 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
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Hemorrhage Hemoglobin Non-invasive monitoring Medical device accuracy |
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Hemorrhage Pathologic Processes |