Conjugated Hyperbilirubinemia and Pulse Oximetry

Emory University

Status: Terminated

Conditions: Hyperbilirubinemia; Liver Disease

Treatments: Procedure: Direct and Indirect Serum Bilirubin Measurement; Procedure: Arterial Blood Gas; Procedure: Pulse Oximetry Machine

Study type: Interventional

Funder types: Other

Identifiers

NCT00741117

IRB00008493

Details and patient eligibility

About

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.

Enrollment: 4 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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4 participants in 3 patient groups

Low Bilirubin Group

Active Comparator group

Description:

Low Bilirubin Group: subjects with a bilirubin level less than or equal to 10 mg/dl

Treatment:

Procedure: Pulse Oximetry Machine

Procedure: Direct and Indirect Serum Bilirubin Measurement

Procedure: Arterial Blood Gas

Medium Bilirubin Group

Active Comparator group

Description:

Medium Bilirubin Group: subjects with a bilirubin level from 11mg/dl to 30 mg/dl

Treatment:

Procedure: Pulse Oximetry Machine

Procedure: Direct and Indirect Serum Bilirubin Measurement

Procedure: Arterial Blood Gas

High Bilirubin Group

Active Comparator group

Description:

High Bilirubin Group: subjects with a bilirubin level greater than or equal to 30 mg/dl

Treatment:

Procedure: Pulse Oximetry Machine

Procedure: Direct and Indirect Serum Bilirubin Measurement

Procedure: Arterial Blood Gas