Conjugated Hyperbilirubinemia and Pulse Oximetry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

4 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2011-10-31

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.

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Detailed Description

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Conditions

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Liver Disease Hyperbilirubinemia

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Low Bilirubin Group

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

Group Type ACTIVE_COMPARATOR

Arterial Blood Gas

Intervention Type PROCEDURE

One blood gas sample will be obtained from an artery in the arm.

Pulse Oximetry Machine

Intervention Type PROCEDURE

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.

Direct and Indirect Serum Bilirubin Measurement

Intervention Type PROCEDURE

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.

Medium Bilirubin Group

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

Group Type ACTIVE_COMPARATOR

Arterial Blood Gas

Intervention Type PROCEDURE

One blood gas sample will be obtained from an artery in the arm.

Pulse Oximetry Machine

Intervention Type PROCEDURE

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.

Direct and Indirect Serum Bilirubin Measurement

Intervention Type PROCEDURE

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.

High Bilirubin Group

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

Group Type ACTIVE_COMPARATOR

Arterial Blood Gas

Intervention Type PROCEDURE

One blood gas sample will be obtained from an artery in the arm.

Pulse Oximetry Machine

Intervention Type PROCEDURE

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.

Direct and Indirect Serum Bilirubin Measurement

Intervention Type PROCEDURE

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.

Interventions

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Arterial Blood Gas

One blood gas sample will be obtained from an artery in the arm.

Intervention Type 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.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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ABG Pulse Ox hepatic function panel

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No