Study Stopped
Study stopped due to insufficient personnel required to conduct trial.
Conjugated Hyperbilirubinemia and Pulse Oximetry
The Influence of Conjugated Hyperbilirubinemia on Pulse Oximetric Accuracy in Liver Disease
1 other identifier
interventional
4
1 country
1
Brief Summary
The purpose of this study is to determine if higher levels of bilirubin in the blood of people with liver disease affects how accurate a pulse oximeter machine is able to measure the concentration of oxygen in the blood. Previous studies have reported conflicting results regarding the affect of high levels of bilirubin in the blood on the accuracy of the pulse oximeter reading. Initial studies showed an underestimation of the oxygen concentration in the presence of elevated bilirubin. Subsequent studies have suggested that high levels of bilirubin in the blood do not influence the accuracy of the pulse oximeter machine. However, recent reports in bone marrow transplant literature and our personal observations in patients with liver disease suggest that high bilirubin levels are associated with an overestimation of the oxygen concentration as measured by the pulse oximeter machine.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2008
CompletedFirst Posted
Study publicly available on registry
August 26, 2008
CompletedStudy Start
First participant enrolled
October 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2011
CompletedMarch 6, 2013
March 1, 2013
Same day
August 25, 2008
March 5, 2013
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of pulse oximetric saturation and calculated oxygen saturation.
Enrollment visit
Study Arms (3)
Low Bilirubin Group
ACTIVE COMPARATORLow Bilirubin Group: subjects with a bilirubin level less than or equal to 10 mg/dl
Medium Bilirubin Group
ACTIVE COMPARATORMedium Bilirubin Group: subjects with a bilirubin level from 11mg/dl to 30 mg/dl
High Bilirubin Group
ACTIVE COMPARATORHigh Bilirubin Group: subjects with a bilirubin level greater than or equal to 30 mg/dl
Interventions
One blood gas sample will be obtained from an artery in the arm.
A pulse oximetry machine will be used at one time point to obtain an oxygen saturation reading. This is done by placing a clip onto the finger. The pulse oximetry value displays on the pulse oximeter machine within seconds.
One tube of blood will be drawn from a vein in the arm at one timepoint to measure the direct and indirect serum bilirubin levels.
Eligibility Criteria
You may qualify if:
- Patients with established liver disease or dysfunction, as determined by abnormal liver function tests, imaging, or biopsy
You may not qualify if:
- Patients with unconjugated hyperbilirubinemia, which could be associated with elevations in carboxyhemoglobin
- Patients with poor peripheral perfusion that would compromise accurate pulse oximetric determination
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Emory Universitylead
Study Sites (1)
Emory University Hospital
Atlanta, Georgia, 30322, United States
Related Publications (6)
Staudinger T, Locker GJ, Frass M, Kalhs P. Misleading high values of oxygen saturation measured by pulse oximetry in excessive hyperbilirubinaemia after BMT. Bone Marrow Transplant. 1996 Nov;18(5):1025. No abstract available.
PMID: 8932862BACKGROUNDVeyckemans F, Baele P, Guillaume JE, Willems E, Robert A, Clerbaux T. Hyperbilirubinemia does not interfere with hemoglobin saturation measured by pulse oximetry. Anesthesiology. 1989 Jan;70(1):118-22. doi: 10.1097/00000542-198901000-00022.
PMID: 2912292BACKGROUNDRamanathan R, Durand M, Larrazabal C. Pulse oximetry in very low birth weight infants with acute and chronic lung disease. Pediatrics. 1987 Apr;79(4):612-7.
PMID: 2434913BACKGROUNDPraud JP, Carofilis A, Bridey F, Lacaille F, Dehan M, Gaultier CL. Accuracy of two wavelength pulse oximetry in neonates and infants. Pediatr Pulmonol. 1989;6(3):180-2. doi: 10.1002/ppul.1950060310.
PMID: 2470014BACKGROUNDRalston AC, Webb RK, Runciman WB. Potential errors in pulse oximetry. III: Effects of interferences, dyes, dyshaemoglobins and other pigments. Anaesthesia. 1991 Apr;46(4):291-5. doi: 10.1111/j.1365-2044.1991.tb11501.x.
PMID: 2024749BACKGROUNDAmazon K, Soloni F, Rywlin AM. Separation of bilirubin from hemoglobin by recording derivative spectrophotometry. Am J Clin Pathol. 1981 Apr;75(4):519-23. doi: 10.1093/ajcp/75.4.519.
PMID: 7223716BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ram Subramanian, MD
Emory University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- M.D. Department of Medicine, Hepatology
Study Record Dates
First Submitted
August 25, 2008
First Posted
August 26, 2008
Study Start
October 1, 2011
Primary Completion
October 1, 2011
Study Completion
October 1, 2011
Last Updated
March 6, 2013
Record last verified: 2013-03