Non-Invasive Hemoglobin Monitoring in Patients With Hemorrhage

This study has been completed.
Sponsor:
Collaborator:
United States Air Force
Information provided by (Responsible Party):
Betty Tsuei, University of Cincinnati
ClinicalTrials.gov Identifier:
NCT01709786
First received: October 12, 2012
Last updated: June 27, 2016
Last verified: May 2016
  Purpose
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.

Condition
Hemorrhage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-Invasive Hemoglobin Monitoring in the Patient With Suspected Hemorrhage

Resource links provided by NLM:


Further study details as provided by University of Cincinnati:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

    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. ] [ Designated as safety issue: No ]

    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.



Enrollment: 88
Study Start Date: September 2012
Study Completion Date: December 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 100 Years   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admitted to the Surgical Intensive Care Unit of University Hospital, Cincinnati will be eligible for this study if they are at risk of ongoing bleeding and require serial CBC measurements. A patient will not be eligible if he or she is:(1) less than 18 years of age, (2) a prisoner, or if (3) clinicians are unable to take pulse oximetry readings due to injuries, burns, amputations, or related problems.
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01709786

Locations
United States, Ohio
University Hospital
Cincinnati, Ohio, United States, 45219
Sponsors and Collaborators
University of Cincinnati
United States Air Force
  More Information

Publications:

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     History of Changes
Other Study ID Numbers: Tsuei-2012-06 
Study First Received: October 12, 2012
Results First Received: December 14, 2015
Last Updated: June 27, 2016
Health Authority: United States: Institutional Review Board
Individual Participant Data  
Plan to Share IPD: No

Keywords provided by University of Cincinnati:
Hemorrhage
Hemoglobin
Non-invasive monitoring
Medical device accuracy

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on August 23, 2016