Conjugated Hyperbilirubinemia and Pulse Oximetry

Liver Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00741117
• Other study ID #: IRB00008493
• Status: Terminated
• Phase: N/A
• First received: August 25, 2008
• Last updated: March 5, 2013
• Start date: October 2011
• Est. completion date: October 2011

Study information

• Verified date: March 2013
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Hyperbilirubinemia
• Liver Disease
• Liver Diseases

Intervention

Procedure:
• Arterial Blood Gas
One blood gas sample will be obtained from an artery in the arm.
• 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.
• 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.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Emory University

Country where clinical trial is conducted

United States, 

References & Publications (6)

Amazon K, Soloni F, Rywlin AM. Separation of bilirubin from hemoglobin by recording derivative spectrophotometry. Am J Clin Pathol. 1981 Apr;75(4):519-23. — View Citation

Praud JP, Carofilis A, Bridey F, Lacaille F, Dehan M, Gaultier CL. Accuracy of two wavelength pulse oximetry in neonates and infants. Pediatr Pulmonol. 1989;6(3):180-2. — View Citation

Ralston AC, Webb RK, Runciman WB. Potential errors in pulse oximetry. III: Effects of interferences, dyes, dyshaemoglobins and other pigments. Anaesthesia. 1991 Apr;46(4):291-5. Review. — View Citation

Ramanathan R, Durand M, Larrazabal C. Pulse oximetry in very low birth weight infants with acute and chronic lung disease. Pediatrics. 1987 Apr;79(4):612-7. — View Citation

Staudinger T, Locker GJ, Frass M, Kalhs P. Misleading high values of oxygen saturation measured by pulse oximetry in excessive hyperbilirubinaemia after BMT. Bone Marrow Transplant. 1996 Nov;18(5):1025. — View Citation

Veyckemans F, Baele P, Guillaume JE, Willems E, Robert A, Clerbaux T. Hyperbilirubinemia does not interfere with hemoglobin saturation measured by pulse oximetry. Anesthesiology. 1989 Jan;70(1):118-22. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of pulse oximetric saturation and calculated oxygen saturation.		Enrollment visit	Yes