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Study stopped due to insufficient personnel required to conduct trial.
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Low Bilirubin Group | Active Comparator | Low Bilirubin Group: subjects with a bilirubin level less than or equal to 10 mg/dl |
|
| Medium Bilirubin Group | Active Comparator | Medium Bilirubin Group: subjects with a bilirubin level from 11mg/dl to 30 mg/dl |
|
| High Bilirubin Group | Active Comparator | High Bilirubin Group: subjects with a bilirubin level greater than or equal to 30 mg/dl |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arterial Blood Gas | Procedure | One blood gas sample will be obtained from an artery in the arm. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of pulse oximetric saturation and calculated oxygen saturation. | Enrollment visit |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ram Subramanian, MD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University Hospital | Atlanta | Georgia | 30322 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8932862 | Background | 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. | |
| 2912292 | Background | 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. |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| D006932 | Hyperbilirubinemia |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D001784 | Blood Gas Analysis |
| D010092 | Oximetry |
| ID | Term |
|---|---|
| D001774 | Blood Chemical Analysis |
| D019963 | Clinical Chemistry Tests |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
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|
| Pulse Oximetry Machine | 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 | 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. |
|
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| 2434913 | Background | 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. |
| 2470014 | Background | 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. |
| 2024749 | Background | 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. |
| 7223716 | Background | 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. |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D008919 | Investigative Techniques |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |