Healthy
Conditions
Brief summary
This study compares the performance of respiration rate from pleth measured prospectively with either INVSENSOR00032 and/or INVSENSOR00033 devices against the respiration rate derived from the manual scoring of the capnography waveform in healthy adult subjects.
Interventions
DEVICEINVSENSOR00032 and INVSENSOR00033
Investigational pulse oximeter 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
* 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 judgment of the investigator, renders them inappropriate for participation in this 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 * 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 INVSENSOR00032 and/or INVSENSOR00033 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 INVSENSOR00032 and/or INVSENSOR00033 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 |
|---|---|
| INVSENSOR00032 and INVSENSOR00033 Test Group All subjects will be enrolled into the test group and will receive the INVSENSOR00032 and/or INVSENSOR00033 device.
INVSENSOR00032 and INVSENSOR00033: Investigational pulse oximeter device | 27 |
| Total | 27 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | INVSENSOR00032 and INVSENSOR00033 Test Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 26 Participants |
| Race/Ethnicity, Customized African American | 8 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 4 Participants |
| Race/Ethnicity, Customized Caucasian | 6 Participants |
| Race/Ethnicity, Customized Hispanic | 9 Participants |
| Region of Enrollment United States | 27 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 27 |
| other Total, other adverse events | 0 / 27 |
| serious Total, serious adverse events | 0 / 27 |
Outcome results
Primary
RRp Arms of Sensor Accuracy
Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00032 and/or INVSENSOR00033 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 INVSENSOR00032 and/or INVSENSOR00033 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) |
|---|---|---|
| INVSENSOR00032 and INVSENSOR00033 Test Group | RRp Arms of Sensor Accuracy | 2.1 respiration per minute (RPM) |