Healthy
Conditions
Brief 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 the noninvasive HbMet measurement by a Pulse Oximeter Sensor will be assessed by comparison to blood measurements from a laboratory analyzer.
Interventions
DEVICEPulse Oximeter Sensor
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
1. The subject is male or female, aged ≥18 and \<50. 2. The subject is in good general health with no evidence of any medical problems. 3. The subject is fluent in both written and spoken English. 4. The subject has provided informed consent and is willing to comply with the study procedures.
Exclusion criteria
1. The subject is obese (BMI\>30). 2. The subject has a known history of heart disease, lung disease, kidney or liver disease. 3. Diagnosis of asthma, sleep apnea, or use of CPAP. 4. Subject has diabetes. 5. Subject has a clotting disorder. 6. 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. 7. The subject has any other serious systemic illness. 8. The subject is a current smoker. 9. Any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators' would interfere with the sensors working correctly. 10. The subject has a history of fainting or vasovagal response. 11. The subject has a history of sensitivity to local anesthesia or allergy to the study drugs. 12. The subject has a diagnosis of Raynaud's disease. 13. The subject has unacceptable collateral circulation based on exam by the investigator (Allen's test). 14. The subject is pregnant, lactating or trying to get pregnant. 15. The subject has a history of migraine headaches. 16. Th subject is currently taking antidepressants. 17. The subject is unable or unwilling to provide informed consent, or is unable or unwilling to comply with study procedures. 18. The subject has any other condition, which in the opinion of the investigators' would make them unsuitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Methemoglobin Measurement by Arms Calculation | 1-5 hours | Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.In order to obtain the Arms value, the blood sample methemoglobin value is subtracted from the pulse oximeter methemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| R2-25 Sensor All subjects will be enrolled in the test group and will receive R2-25 Pulse Oximeter Sensor
Pulse Oximeter Sensor | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | R2-25 Sensor |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Region of Enrollment United States | 28 participants |
| Sex: Female, Male Female | 10 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 28 |
| other Total, other adverse events | 0 / 28 |
| serious Total, serious adverse events | 0 / 28 |
Outcome results
Primary
Accuracy of Methemoglobin Measurement by Arms Calculation
Accuracy willl be determined by comparing the noninvasive blood methemoglobin measurement (expressed as a percentage of total hemoglobin) of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square(Arms) error value.In order to obtain the Arms value, the blood sample methemoglobin value is subtracted from the pulse oximeter methemoglobin value for a number of samples, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms Error value.
Time frame: 1-5 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| R2-25 Sensor | Accuracy of Methemoglobin Measurement by Arms Calculation | 0.48 percentage of total hemoglobin |