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 measurement by a DCI pulse oximeter sensor will be assessed by comparison to blood measurements from a laboratory analyzer.
Interventions
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
1. Subjects must understand and consent to be in the study 2. American Society of Anesthesiology Class I (Healthy subjects without any systemic disease at all).
Exclusion criteria
1. Subjects who have any systemic disease at all. 2. Subjects who do not understand the study and the risks involved. 3. Current smokers. 4. Subjects who are pregnant.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of Sensor by Arms Calculation | 5 hours | Accuracy will be determined by comparing the noninvasive blood methemoglobin measurement 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 |
|---|---|
| Test Group All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor. | 25 |
| Total | 25 |
Baseline characteristics
| Characteristic | Test Group | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 0 Participants | — |
| Age, Categorical Between 18 and 65 years | 25 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 25 Participants | — |
| Sex: Female, Male Female | 9 Participants | — |
| Sex: Female, Male Male | 16 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
Primary
Accuracy of Sensor by Arms Calculation
Accuracy will be determined by comparing the noninvasive blood methemoglobin measurement 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) |
|---|---|---|
| Test Group | Accuracy of Sensor by Arms Calculation | 0.87 percentage |