Healthy
Conditions
Brief summary
The objective of this prospective study is to compare the noninvasive respiration from pleth (RRp) performance of the Masimo INVSENSOR00013 device against the respiratory rate measured by capnography (RRref), Masimo's RAM technology and the manual annotation.
Interventions
DEVICEINVSENSOR00013
Investigational pulse oximeter device that will be placed on the subject's finger. This will be used as a spotcheck device
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 to 70 years old * Physical status of ASA I or II * Must be able to read and communicate in English * Has signed all necessary related documents, e.g. written informed consent, confidentiality agreement * Passed health assessment screening * Negative pregnancy test for female subjects of child bearing potential
Exclusion criteria
* Physical status of ASA III, IV, or V * Subject has any medical condition which in the judgement of the investigator, renders them inappropriate for participation in the study * Inability to tolerate sitting still or minimal movement for at least 30 minutes * Positive pregnancy test for female subjects * Refusal to take pregnancy test for women of child bearing potential * Nursing female subjects * Refusal of male subjects to agree to shave hair off areas where the sensor will be applied (neck) when deemed necessary * Subjects wearing acrylic nails or subjects refusing to remove nail polish * Subjects who have a nail deformity on the measurement finger * Subjects who do not have adequate skin integrity on the measurement finger * Excluded at the Principal Investigator's discretion
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| RRp Arms of Sensor Accuracy | 1-5 hours | Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00013 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00013 RRp measurement 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 value. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| INVSENSOR00013 Sensor All subjects are enrolled into the test group and all subjects received the INVSENSOR00013 sensor. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | INVSENSOR00013 Sensor |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 28 Participants |
| Race/Ethnicity, Customized African American | 9 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 2 Participants |
| Race/Ethnicity, Customized Caucasian | 9 Participants |
| Race/Ethnicity, Customized Hispanic | 7 Participants |
| Race/Ethnicity, Customized Other | 1 Participants |
| Region of Enrollment United States | 28 Participants |
| Sex: Female, Male Female | 9 Participants |
| Sex: Female, Male Male | 19 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
RRp Arms of Sensor Accuracy
Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00013 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00013 RRp measurement 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 value.
Time frame: 1-5 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INVSENSOR00013 Sensor | RRp Arms of Sensor Accuracy | 1.2 respiration per minute (RPM) |