Conjugated Hyperbilirubinemia and Pulse Oximetry

March 5, 2013 updated by: Ram Subramanian, Emory University

The Influence of Conjugated Hyperbilirubinemia on Pulse Oximetric Accuracy in Liver Disease

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

4

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • hepatic function panel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of pulse oximetric saturation and calculated oxygen saturation.
Time Frame: Enrollment visit
Enrollment visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Ram Subramanian, MD, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

October 1, 2011

Study Completion (Actual)

October 1, 2011

Study Registration Dates

First Submitted

August 25, 2008

First Submitted That Met QC Criteria

August 25, 2008

First Posted (Estimate)

August 26, 2008

Study Record Updates

Last Update Posted (Estimate)

March 6, 2013

Last Update Submitted That Met QC Criteria

March 5, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00008493

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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