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Conjugated Hyperbilirubinemia and Pulse Oximetry

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ClinicalTrials.gov Identifier: NCT00741117
Recruitment Status : Terminated (Study stopped due to insufficient personnel required to conduct trial.)
First Posted : August 26, 2008
Last Update Posted : March 6, 2013
Sponsor:
Information provided by (Responsible Party):
Ram Subramanian, Emory University

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.

Condition or disease Intervention/treatment Phase
Liver Disease Hyperbilirubinemia Procedure: Arterial Blood Gas Procedure: Pulse Oximetry Machine Procedure: Direct and Indirect Serum Bilirubin Measurement Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: The Influence of Conjugated Hyperbilirubinemia on Pulse Oximetric Accuracy in Liver Disease
Study Start Date : October 2011
Actual Primary Completion Date : October 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Comparison of pulse oximetric saturation and calculated oxygen saturation. [ Time Frame: Enrollment visit ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

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): 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

Publications:
Responsible Party: Ram Subramanian, M.D. Department of Medicine, Hepatology, Emory University
ClinicalTrials.gov Identifier: NCT00741117     History of Changes
Other Study ID Numbers: IRB00008493
First Posted: August 26, 2008    Key Record Dates
Last Update Posted: March 6, 2013
Last Verified: March 2013

Keywords provided by Ram Subramanian, Emory University:
Pulse Oximetry
Blood Gas Analysis
Liver Disease
Hyperbilirubinemia

Additional relevant MeSH terms:
Liver Diseases
Hyperbilirubinemia
Digestive System Diseases
Pathologic Processes
Bilirubin
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs