N/A
N=51
Accuracy of Methemoglobin Measurement for Rainbow Universal Pulse Oximeter Sensor
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03125005 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Jun 2017
Primary outcome: Primary: Accuracy of Sensor by Arms Calculation — 0.63 Percentage of total hemoglobin
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rainbow Universal Pulse Oximeter Sensor (Device)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Jun 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Accuracy of Sensor by Arms Calculation |
0.63 | — |
Summary
In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of a noninvasive HbMet sensor will be assessed by comparison to blood measurements from a laboratory analyzer.
Eligibility Criteria
Inclusion Criteria
- The subject is male or female, aged ≥18 and 30).
- The subject has a known history of heart disease, lung disease, kidney or liver disease.
- Diagnosis of asthma, sleep apnea, or use of CPAP.
- Subject has diabetes.
- Subject has a clotting disorder.
- The subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
- The subject has any other serious systemic illness.
- The subject is a current smoker.
- Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly.
- The subject has a history of fainting or vasovagal response.
- The subject has a history of sensitivity to local anesthesia or allergy to the study drugs.
- The subject has a diagnosis of Raynaud's disease.
- The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
- The subject is pregnant, lactating or trying to get pregnant.
- The subject has a history of migraine headaches.
- The subject is currently taking antidepressants.
- The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures.
- The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
Data sourced from ClinicalTrials.gov (NCT03125005). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.