Conjugated Hyperbilirubinemia and Pulse Oximetry - Full Text View

Purpose

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.

Condition	Intervention
Liver Disease Hyperbilirubinemia	Procedure: Arterial Blood Gas Procedure: Pulse Oximetry Machine Procedure: Direct and Indirect Serum Bilirubin Measurement

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Diagnostic
Official Title:	The Influence of Conjugated Hyperbilirubinemia on Pulse Oximetric Accuracy in Liver Disease

Resource links provided by NLM:

Genetics Home Reference related topics: Dubin-Johnson syndrome

MedlinePlus related topics: Gas Jaundice Liver Diseases Oxygen Therapy

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:

Comparison of pulse oximetric saturation and calculated oxygen saturation. [ Time Frame: Enrollment visit ] [ Designated as safety issue: Yes ]

Enrollment:	4
Study Start Date:	October 2011
Study Completion Date:	October 2011
Primary Completion Date:	October 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Low Bilirubin Group Low Bilirubin Group: subjects with a bilirubin level less than or equal to 10 mg/dl	Procedure: Arterial Blood Gas One blood gas sample will be obtained from an artery in the arm. Other Name: ABG Procedure: Pulse Oximetry Machine 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. Other Name: Pulse Ox Procedure: Direct and Indirect Serum Bilirubin Measurement 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. Other Name: hepatic function panel
Active Comparator: Medium Bilirubin Group Medium Bilirubin Group: subjects with a bilirubin level from 11mg/dl to 30 mg/dl	Procedure: Arterial Blood Gas One blood gas sample will be obtained from an artery in the arm. Other Name: ABG Procedure: Pulse Oximetry Machine 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. Other Name: Pulse Ox Procedure: Direct and Indirect Serum Bilirubin Measurement 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. Other Name: hepatic function panel
Active Comparator: High Bilirubin Group High Bilirubin Group: subjects with a bilirubin level greater than or equal to 30 mg/dl	Procedure: Arterial Blood Gas One blood gas sample will be obtained from an artery in the arm. Other Name: ABG Procedure: Pulse Oximetry Machine 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. Other Name: Pulse Ox Procedure: Direct and Indirect Serum Bilirubin Measurement 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. Other Name: hepatic function panel

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00741117

Locations

United States, Georgia
Emory University Hospital
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:

Ram Subramanian, MD

Emory University

More Information

Publications:

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.

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.

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.

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.

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. Review.

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.

Responsible Party:	Ram Subramanian, M.D. Department of Medicine, Hepatology, Emory University
ClinicalTrials.gov Identifier:	NCT00741117 History of Changes
Other Study ID Numbers:	IRB00008493
Study First Received:	August 25, 2008
Last Updated:	March 5, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Pulse Oximetry
Blood Gas Analysis
Liver Disease
Hyperbilirubinemia

Additional relevant MeSH terms:

Hyperbilirubinemia
Liver Diseases
Pathologic Processes
Digestive System Diseases
Bilirubin

Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Protective Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 22, 2013