Conjugated Hyperbilirubinemia and Pulse Oximetry

Not Applicable

Terminated

• Conditions: Liver Disease; Hyperbilirubinemia
• Interventions: Procedure: Arterial Blood Gas; Procedure: Pulse Oximetry Machine; Procedure: Direct and Indirect Serum Bilirubin Measurement

• Registration Number: NCT00741117
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-08-25
• Study First Submitted QC: 2008-08-25
• Study First Posted: 2008-08-26
• Study Start: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-05
• Last Update Posted: 2013-03-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 4

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Bilirubin Group	Arterial Blood Gas	Low Bilirubin Group: subjects with a bilirubin level less than or equal to 10 mg/dl
Low Bilirubin Group	Pulse Oximetry Machine	Low Bilirubin Group: subjects with a bilirubin level less than or equal to 10 mg/dl
Low Bilirubin Group	Direct and Indirect Serum Bilirubin Measurement	Low Bilirubin Group: subjects with a bilirubin level less than or equal to 10 mg/dl
Medium Bilirubin Group	Pulse Oximetry Machine	Medium Bilirubin Group: subjects with a bilirubin level from 11mg/dl to 30 mg/dl
Medium Bilirubin Group	Arterial Blood Gas	Medium Bilirubin Group: subjects with a bilirubin level from 11mg/dl to 30 mg/dl
Medium Bilirubin Group	Direct and Indirect Serum Bilirubin Measurement	Medium Bilirubin Group: subjects with a bilirubin level from 11mg/dl to 30 mg/dl
High Bilirubin Group	Arterial Blood Gas	High Bilirubin Group: subjects with a bilirubin level greater than or equal to 30 mg/dl
High Bilirubin Group	Pulse Oximetry Machine	High Bilirubin Group: subjects with a bilirubin level greater than or equal to 30 mg/dl
High Bilirubin Group	Direct and Indirect Serum Bilirubin Measurement	High Bilirubin Group: subjects with a bilirubin level greater than or equal to 30 mg/dl

Primary Outcome Measures

Name	Time	Method
Comparison of pulse oximetric saturation and calculated oxygen saturation.	Enrollment visit

Trial Locations

Locations (1)

Emory University Hospital; 🇺🇸 Atlanta, Georgia, United States