Clinical trial NCT00741117: Conjugated Hyperbilirubinemia and Pulse Oximetry
Official title: The Influence of Conjugated Hyperbilirubinemia on Pulse Oximetric Accuracy in Liver Disease
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Liver Disease
Hyperbilirubinemia
Keywords: Pulse Oximetry
Blood Gas Analysis
Liver Disease
Hyperbilirubinemia
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2008-08-26
Enrollment: 4
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Comparison of pulse oximetric saturation and calculated oxygen saturation.
timeFrame: Enrollment visit
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University Hospital
state: Georgia
Study officials:
affiliation: Emory University
name: Ram Subramanian, MD
role: PRINCIPAL_INVESTIGATOR
References:
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. No abstract available.
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. doi: 10.1097/00000542-198901000-00022.
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.
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. doi: 10.1002/ppul.1950060310.
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. doi: 10.1111/j.1365-2044.1991.tb11501.x.
citation: 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. doi: 10.1093/ajcp/75.4.519.