Conjugated Hyperbilirubinemia and Pulse Oximetry

This study has been terminated.
(Study stopped due to insufficient personnel required to conduct trial.)
Sponsor:
Information provided by (Responsible Party):
Ram Subramanian, Emory University
ClinicalTrials.gov Identifier:
NCT00741117
First received: August 25, 2008
Last updated: March 5, 2013
Last verified: March 2013
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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 August 26, 2014