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 a noninvasive HbMet sensor will be assessed by comparison to blood measurements from a laboratory analyzer.
Interventions
DEVICERainbow Universal Pulse 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
* The subject is male or female, aged ≥18 and \<50. * The subject is in good general health with no evidence of any medical problems. * The subject is fluent in both written and spoken English. * The subject has provided informed consent and is willing to comply with the study procedures.
Exclusion criteria
* The subject is obese (BMI\>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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Sensor by Arms Calculation | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Rainbow Universal Pulse Oximeter Sensor All subjects will be enrolled in the test group and will receive Rainbow Universal Pulse Oximeter Sensor.
Rainbow Universal Pulse Oximeter Sensor | 51 |
| Total | 51 |
Baseline characteristics
| Characteristic | Rainbow Universal Pulse Oximeter Sensor |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 51 Participants |
| Region of Enrollment United States | 51 participants |
| Sex: Female, Male Female | 29 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 51 |
| other Total, other adverse events | 0 / 51 |
| serious Total, serious adverse events | 0 / 51 |
Outcome results
Primary
Accuracy of Sensor 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.
Time frame: 5 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Rainbow Universal Pulse Oximeter Sensor | Accuracy of Sensor by Arms Calculation | 0.63 Percentage of total hemoglobin |