Dysfunctional Hemoglobin
1 other identifier
observational
62
1 country
1
Brief Summary
The purpose of the study is to determine if a new pulse oximeter accurately detects carboxyhemoglobin and methemoglobin when intentionally increased in the blood.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Oct 2014
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2014
CompletedFirst Submitted
Initial submission to the registry
October 7, 2014
CompletedFirst Posted
Study publicly available on registry
October 10, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2015
CompletedApril 21, 2015
October 1, 2014
5 months
October 7, 2014
April 20, 2015
Conditions
Outcome Measures
Primary Outcomes (2)
Evaluate carboxyhemoglobin over the range of 0-15 percent as assessed by co-oximetry
4 hours
Evaluate methemoglobin over the range of 0-15 percent as assessed by co-oximetry
4 hours
Secondary Outcomes (2)
Determine oxygen saturation accuracy in conditions of elevated carboxyhemoglobin
4 hours
Determine oxygen saturation accuracy in conditions of elevated methemoglobin
4 hours
Study Arms (2)
Carboxyhemoglobin
Induced carboxyhemoglobin levels up tp 15 percent.
Methemoglobin
Induced methemoglobin levels up to 15 percent.
Interventions
Comparison of pulse co-oximeters
Eligibility Criteria
Healthy Adult volunteers
You may qualify if:
- Subjects does not have significant medical problems
- Subject is willing to provide written informed consent
- Subject is between 18 and 45 years of age
You may not qualify if:
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nonin Medical, Inclead
- University of California, San Franciscocollaborator
Study Sites (1)
University of California San Francisco
San Francisco, California, 94118, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Phillip E Bickler, MD, PhD
University of San Francisco
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 7, 2014
First Posted
October 10, 2014
Study Start
October 1, 2014
Primary Completion
March 1, 2015
Study Completion
March 1, 2015
Last Updated
April 21, 2015
Record last verified: 2014-10