Conjugated Hyperbilirubinemia and Pulse Oximetry

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Disease, Hyperbilirubinemia

Intervention / Treatment
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* Procedure: Arterial Blood Gas
* Procedure: Pulse Oximetry Machine
* Procedure: Direct and Indirect Serum Bilirubin Measurement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low Bilirubin Group<br>Low Bilirubin Group: subjects with a bilirubin level less than or equal to 10 mg/dl | Procedure: Arterial Blood Gas<br>* One blood gas sample will be obtained from an artery in the arm.<br>* Other names: ABG;Procedure: Pulse Oximetry Machine<br>* 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.<br>* Other names: Pulse Ox;Procedure: Direct and Indirect Serum Bilirubin Measurement<br>* 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.<br>* Other names: hepatic function panel;|
| Active Comparator: Medium Bilirubin Group<br>Medium Bilirubin Group: subjects with a bilirubin level from 11mg/dl to 30 mg/dl | Procedure: Arterial Blood Gas<br>* One blood gas sample will be obtained from an artery in the arm.<br>* Other names: ABG;Procedure: Pulse Oximetry Machine<br>* 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.<br>* Other names: Pulse Ox;Procedure: Direct and Indirect Serum Bilirubin Measurement<br>* 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.<br>* Other names: hepatic function panel;|
| Active Comparator: High Bilirubin Group<br>High Bilirubin Group: subjects with a bilirubin level greater than or equal to 30 mg/dl | Procedure: Arterial Blood Gas<br>* One blood gas sample will be obtained from an artery in the arm.<br>* Other names: ABG;Procedure: Pulse Oximetry Machine<br>* 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.<br>* Other names: Pulse Ox;Procedure: Direct and Indirect Serum Bilirubin Measurement<br>* 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.<br>* Other names: hepatic function panel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of pulse oximetric saturation and calculated oxygen saturation. |  | Enrollment visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pulse Oximetry, Blood Gas Analysis, Liver Disease, Hyperbilirubinemia