Back to resultsConjugated Hyperbilirubinemia and Pulse Oximetry
Primary Purpose
Liver Disease, Hyperbilirubinemia
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arterial Blood Gas
Pulse Oximetry Machine
Direct and Indirect Serum Bilirubin Measurement
Sponsored by
About this trial
This is an interventional diagnostic trial for Liver Disease focused on measuring Pulse Oximetry, Blood Gas Analysis, Liver Disease, Hyperbilirubinemia
Eligibility Criteria
Inclusion Criteria:
- Patients with established liver disease or dysfunction, as determined by abnormal liver function tests, imaging, or biopsy
Exclusion Criteria:
- Patients with unconjugated hyperbilirubinemia, which could be associated with elevations in carboxyhemoglobin
- Patients with poor peripheral perfusion that would compromise accurate pulse oximetric determination
Sites / Locations
- Emory University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Low Bilirubin Group
Medium Bilirubin Group
High Bilirubin Group
Arm Description
Low Bilirubin Group: subjects with a bilirubin level less than or equal to 10 mg/dl
Medium Bilirubin Group: subjects with a bilirubin level from 11mg/dl to 30 mg/dl
High Bilirubin Group: subjects with a bilirubin level greater than or equal to 30 mg/dl
Outcomes
Primary Outcome Measures
Comparison of pulse oximetric saturation and calculated oxygen saturation.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00741117
Brief Title
Conjugated Hyperbilirubinemia and Pulse Oximetry
Official Title
The Influence of Conjugated Hyperbilirubinemia on Pulse Oximetric Accuracy in Liver Disease
Study Type
Interventional
2. Study Status
Record Verification Date
March 2013
Overall Recruitment Status
Terminated
Why Stopped
Study stopped due to insufficient personnel required to conduct trial.
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Emory University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Disease, Hyperbilirubinemia
Keywords
Pulse Oximetry, Blood Gas Analysis, Liver Disease, Hyperbilirubinemia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
4 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Low Bilirubin Group
Arm Type
Active Comparator
Arm Description
Low Bilirubin Group: subjects with a bilirubin level less than or equal to 10 mg/dl
Arm Title
Medium Bilirubin Group
Arm Type
Active Comparator
Arm Description
Medium Bilirubin Group: subjects with a bilirubin level from 11mg/dl to 30 mg/dl
Arm Title
High Bilirubin Group
Arm Type
Active Comparator
Arm Description
High Bilirubin Group: subjects with a bilirubin level greater than or equal to 30 mg/dl
Intervention Type
Procedure
Intervention Name(s)
Arterial Blood Gas
Other Intervention Name(s)
ABG
Intervention Description
One blood gas sample will be obtained from an artery in the arm.
Intervention Type
Procedure
Intervention Name(s)
Pulse Oximetry Machine
Other Intervention Name(s)
Pulse Ox
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Direct and Indirect Serum Bilirubin Measurement
Other Intervention Name(s)
hepatic function panel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Comparison of pulse oximetric saturation and calculated oxygen saturation.
Time Frame
Enrollment visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with established liver disease or dysfunction, as determined by abnormal liver function tests, imaging, or biopsy
Exclusion Criteria:
Patients with unconjugated hyperbilirubinemia, which could be associated with elevations in carboxyhemoglobin
Patients with poor peripheral perfusion that would compromise accurate pulse oximetric determination
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ram Subramanian, MD
Organizational Affiliation
Emory University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
8932862
Citation
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.
Results Reference
background
PubMed Identifier
2912292
Citation
Veyckemans 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.
Results Reference
background
PubMed Identifier
2434913
Citation
Ramanathan 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.
Results Reference
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PubMed Identifier
2470014
Citation
Praud 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.
Results Reference
background
PubMed Identifier
2024749
Citation
Ralston 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.
Results Reference
background
PubMed Identifier
7223716
Citation
Amazon 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.
Results Reference
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Conjugated Hyperbilirubinemia and Pulse Oximetry
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