Accuracy of Detection of Methemoglobin With Pulse Oximetry (NCT03869840) | Clinical Trial Compass
CompletedNot Applicable
Accuracy of Detection of Methemoglobin With Pulse Oximetry
United States13 participantsStarted 2019-03-26
Plain-language summary
The non-invasive measurement of dysfunctional hemoglobins allows physicians to monitor levels in affected individuals without requiring blood samples or laboratory testing. Nonin Medical Inc, has recently developed a multi-wavelength device that measures carboxyhemoglobin and methemoglobin non-invasively. The primary objective of this study is to validate %MetHb and SpO2 accuracy performance of the study device. Evaluations will be for the range of 0 to 15% MetHb with 95-100% SaO2 as assessed by CO-oximetry, and 0-15% MetHb accuracy under conditions of elevated HHb (SaO2 80-100%) as assessed by CO-oximetry, and SpO2 with 80-100% SaO2 during elevated MetHb as assessed by CO-oximetry.
Who can participate
Age range
18 Years – 50 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* The subject is male or female.
* The subject is of any racial or ethnic group.
* The subject is between 18 years and 50 years of age (self-reported).
* The subject does not have significant medical problems (self-reported).
* The subject is willing to provide written informed consent and is willing and able to comply with study procedures.
Exclusion Criteria:
* Has a BMI greater than 31 (calculated from self-reported weight and height).
* Has had any relevant injury at the sensor location site (self-reported).
* Has a deformity or abnormalities that may prevent proper application of the device under test (based on visual inspection).
* Has a known respiratory condition (self-reported).
* Is currently a smoker (self-reported).
* Has a known heart or cardiovascular condition (self-reported).
* Is currently pregnant (self-reported).
* Is female and actively trying to get pregnant (self-reported).
* Has a clotting disorder (self-reported).
* Has Raynaud's Disease (self-reported).
* Is known to have a hemoglobinopathy such as (anemia, bilirubinemia, sickle-cell anemia, inherited or congenital methemoglobinemia) (self-reported).
* The subject has a COHb greater than 3% or MetHb greater than 2% (based on the first blood sample analysis).
* Has taken blood thinners or medication with aspirin within the last 24 hours (self-reported).
* Has unacceptable collateral circulation from the ulnar artery (based on exam).
* Has donated more than 300 mL of blood within …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.