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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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4 May 2015 |
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Main ID: |
NCT02262195 |
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Date of registration:
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07/10/2014 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Dysfunctional Hemoglobin
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Scientific title:
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Dysfunctional Hemoglobin Pulse Co-ox |
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Date of first enrolment:
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October 2014 |
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Target sample size:
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62 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT02262195 |
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Study type:
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Observational |
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Study design:
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Observational Model: Cohort, Time Perspective: Prospective
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Phase:
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N/A
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Countries of recruitment
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United States
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Contacts
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Name:
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Phillip E Bickler, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of San Francisco |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Subjects does not have significant medical problems
- Subject is willing to provide written informed consent
- Subject is between 18 and 45 years of age
Exclusion Criteria:
- Has a BMI greater than 31
- Has had any relevant injury at the sensor location site
- Has deformities or abnormalities that may prevent proper application of the device
under test
- Has a known respiratory condition
- Is currently a smoker
- Has a known heart or cardiovascular condition
- Is currently pregnant
- Is female and actively trying to get pregnant
- Has a clotting disorder
- Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell
anemia, inherited or congenital methemoglobinemia)
- The subject has a COHb greater than 3% or MetHb greater than 2%
- Has taken blood thinners or medication with aspirin within the last 24 hours
- Has unacceptable collateral circulation from the ulnar artery
- Has donated more than 300 mL of blood within one month prior to start of study
- Is unwilling or unable to provide written informed consent to participate in the
study
- Is unwilling or unable to comply with the study procedures
- Has another health condition which in the opinion of the principal investigator makes
him/her unsuitable for testing
Age minimum:
18 Years
Age maximum:
45 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Elevated Levels of Carboxyhemoglobin and Methemoglobin
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Intervention(s)
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Other: Elevated levels of carboxyhemoglobin
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Primary Outcome(s)
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Evaluate methemoglobin over the range of 0-15 percent as assessed by co-oximetry
[Time Frame: 4 hours]
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Evaluate carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry
[Time Frame: 4 hours]
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Secondary Outcome(s)
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Determine oxygen saturation accuracy in conditions of elevated carboxyhemoglobin
[Time Frame: 4 hours]
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Determine oxygen saturation accuracy in conditions of elevated methemoglobin
[Time Frame: 4 hours]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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