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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

August 25, 2008
March 5, 2013
October 2011
October 2011   (final data collection date for primary outcome measure)
Comparison of pulse oximetric saturation and calculated oxygen saturation. [ Time Frame: Enrollment visit ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00741117 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Conjugated Hyperbilirubinemia and Pulse Oximetry
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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Liver Disease
  • Hyperbilirubinemia
  • 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: Low Bilirubin Group
    Low Bilirubin Group: subjects with a bilirubin level less than or equal to 10 mg/dl
    Interventions:
    • Procedure: Arterial Blood Gas
    • Procedure: Pulse Oximetry Machine
    • Procedure: Direct and Indirect Serum Bilirubin Measurement
  • Active Comparator: Medium Bilirubin Group
    Medium Bilirubin Group: subjects with a bilirubin level from 11mg/dl to 30 mg/dl
    Interventions:
    • Procedure: Arterial Blood Gas
    • Procedure: Pulse Oximetry Machine
    • Procedure: Direct and Indirect Serum Bilirubin Measurement
  • Active Comparator: High Bilirubin Group
    High Bilirubin Group: subjects with a bilirubin level greater than or equal to 30 mg/dl
    Interventions:
    • Procedure: Arterial Blood Gas
    • Procedure: Pulse Oximetry Machine
    • Procedure: Direct and Indirect Serum Bilirubin Measurement

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
4
October 2011
October 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00741117
IRB00008493
No
Ram Subramanian, Emory University
Emory University
Not Provided
Principal Investigator: Ram Subramanian, MD Emory University
Emory University
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP