Liver DiseaseNCT00741117
Conjugated Hyperbilirubinemia and Pulse Oximetry
A study testing Arterial Blood Gas, Pulse Oximetry Machine and Direct and Indirect Serum Bilirubin Measurement in people with Liver Disease and Hyperbilirubinemia, run by Emory University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Disease, Hyperbilirubinemia
- What is being tested?
- Arterial Blood Gas, Pulse Oximetry Machine and Direct and Indirect Serum Bilirubin Measurement
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2011to Oct 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with established liver disease or dysfunction, as determined by abnormal liver function tests, imaging, or biopsy
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: The Influence of Conjugated Hyperbilirubinemia on Pulse Oximetric Accuracy in Liver Disease
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.
- Conditions
- Liver Disease, Hyperbilirubinemia
- Being tested
- Arterial Blood Gas, Pulse Oximetry Machine, Direct and Indirect Serum Bilirubin Measurement
- Keywords
- Pulse Oximetry, Blood Gas Analysis, Liver Disease, Hyperbilirubinemia
- Medical subject headings
- Liver Diseases, Hyperbilirubinemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial Blood GasProcedure or surgery
Also called ABG
One blood gas sample will be obtained from an artery in the arm.
Pulse Oximetry MachineProcedure or surgery
Also called Pulse Ox
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 MeasurementProcedure or surgery
Also called hepatic function panel
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Bilirubin Group | Active comparator | Low Bilirubin Group: subjects with a bilirubin level less than or equal to 10 mg/dl Receives: Procedure: Arterial Blood Gas; Procedure: Pulse Oximetry Machine; Procedure: Direct and Indirect Serum Bilirubin Measurement |
| Medium Bilirubin Group | Active comparator | Medium Bilirubin Group: subjects with a bilirubin level from 11mg/dl to 30 mg/dl Receives: Procedure: Arterial Blood Gas; Procedure: Pulse Oximetry Machine; Procedure: Direct and Indirect Serum Bilirubin Measurement |
| High Bilirubin Group | Active comparator | High Bilirubin Group: subjects with a bilirubin level greater than or equal to 30 mg/dl Receives: Procedure: Arterial Blood Gas; Procedure: Pulse Oximetry Machine; Procedure: Direct and Indirect Serum Bilirubin Measurement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of pulse oximetric saturation and calculated oxygen saturation.
Measured: Enrollment visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2008 (estimated)
- Study startOct 2011
- Primary completionOct 2011
- Study completionOct 2011
Why it stopped: Study stopped due to insufficient personnel required to conduct trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Liver DiseaseStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ram Subramanian, Emory University
- Investigators
- Ram Subramanian, MD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00741117
- Sponsor's protocol ID
- IRB00008493
- Status last verified
- Mar 2013
- First submitted
- 25 Aug 2008
- Last updated
- 6 Mar 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 8932862Veyckemans 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.
PubMed 2912292Ramanathan 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.
PubMed 2434913Praud 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.
PubMed 2470014Ralston 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.
PubMed 2024749Amazon 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.
PubMed 7223716
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Conjugated Hyperbilirubinemia on Pulse Oximetric Accuracy in Liver Disease
- ClinicalTrials.gov ID
- NCT00741117
- Acronym / sponsor ID
- IRB00008493
- Conditions
- Liver Disease, Hyperbilirubinemia
- Keywords
- Pulse Oximetry, Blood Gas Analysis, Liver Disease, Hyperbilirubinemia
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study stopped due to insufficient personnel required to conduct trial.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 26 Aug 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low Bilirubin Group | Active comparator | Procedure: Arterial Blood Gas, Procedure: Pulse Oximetry Machine, Procedure: Direct and Indirect Serum Bilirubin MeasurementLow Bilirubin Group: subjects with a bilirubin level less than or equal to 10 mg/dl |
| Medium Bilirubin Group | Active comparator | Procedure: Arterial Blood Gas, Procedure: Pulse Oximetry Machine, Procedure: Direct and Indirect Serum Bilirubin MeasurementMedium Bilirubin Group: subjects with a bilirubin level from 11mg/dl to 30 mg/dl |
| High Bilirubin Group | Active comparator | Procedure: Arterial Blood Gas, Procedure: Pulse Oximetry Machine, Procedure: Direct and Indirect Serum Bilirubin MeasurementHigh Bilirubin Group: subjects with a bilirubin level greater than or equal to 30 mg/dl |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with established liver disease or dysfunction, as determined by abnormal liver function tests, imaging, or biopsy
Key exclusion criteria (2 listed)
- Patients with unconjugated hyperbilirubinemia, which could be associated with elevations in carboxyhemoglobin
- Patients with poor peripheral perfusion that would compromise accurate pulse oximetric determination
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial Blood GasAlso: ABGOne blood gas sample will be obtained from an artery in the arm. | Procedure or surgery | High Bilirubin Group, Low Bilirubin Group, Medium Bilirubin Group |
| Pulse Oximetry MachineAlso: Pulse OxA 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. | Procedure or surgery | High Bilirubin Group, Low Bilirubin Group, Medium Bilirubin Group |
| Direct and Indirect Serum Bilirubin MeasurementAlso: hepatic function panelOne tube of blood will be drawn from a vein in the arm at one timepoint to measure the direct and indirect serum bilirubin levels. | Procedure or surgery | High Bilirubin Group, Low Bilirubin Group, Medium Bilirubin Group |
Primary outcome
Comparison of pulse oximetric saturation and calculated oxygen saturation.
Time frame: Enrollment visit
Results and safety
The study was stopped early (reason given: Study stopped due to insufficient personnel required to conduct trial.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2013.
- Background: PubMed 8932862Staudinger 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.
- Background: PubMed 2912292Veyckemans 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.
- Background: PubMed 2434913Ramanathan 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.
- Background: PubMed 2470014Praud 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.
- Background: PubMed 2024749Ralston 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.
- Background: PubMed 7223716Amazon 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ram Subramanian, MD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Arterial Blood Gas, Pulse Oximetry Machine and Direct and Indirect Serum Bilirubin Measurement in people with Liver Disease and Hyperbilirubinemia, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Mar 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Study stopped due to insufficient personnel required to conduct trial.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of pulse oximetric saturation and calculated oxygen saturation. (time frame: Enrollment visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00741117, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2013.