Healthy
Conditions
Brief summary
This study assesses the investigational sensor's (INVSENSOR00027) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.
Interventions
DEVICEINVSENSOR00027
Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate.
Sponsors
Masimo Corporation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* 18 to 80 years old * Physical status of ASA I or II * Subjects must be able to read and communicate in English * Has signed all necessary related documents, e.g. written informed consent, volunteer payment form, confidentiality agreement * Has completed Health Assessment Questionnaire and passed health assessment screening
Exclusion criteria
* 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 * Nursing female volunteers * Excluded at the Principal Investigator's discretion * Refusal to take the pregnancy test (for female subjects) * Positive pregnancy test for female subjects of child bearing potential. This is done for the safety of this population. * Refusal to shave hair (neck, chest) off areas where sensors will be applied (male subjects)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of INVSENSOR00027's Posture Change Detection | 1-5 hours | For each subject's position detection, INVSENSOR00027 output will be compared against observer's notes at each turn of the subject. Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection) |
| Sensitivity of INVSENSOR00027's Activity Change Detection | 1-5 hours | For each subject's activity (e.g., walking and upright) detection, INVSENSOR00027 output will be compared against observer's notes. Correctly detected activity changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's activity change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection). |
| Sensitivity of INVSENSOR00027's Fall Event Detection | 1-5 hours | — |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Rate Detection | 1-5 hours | Accuracy will be determined by comparing the respiratory rate measurement of the INVSENSOR00027 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 INVSENSOR00027 RR 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 |
|---|---|
| INVSENSOR00027 Test Group The subjects will be enrolled into the test group and will receive the INVSENSOR00027 investigational sensor.
INVSENSOR00027: Investigational, noninvasive sensor that will be placed on the subject's chest and/or back. INVSENSOR00027 measures signals regarding subject's movement and posture, heart rate, and respiratory rate. | 40 |
| Total | 40 |
Baseline characteristics
| Characteristic | INVSENSOR00027 Test Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 2 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Race/Ethnicity, Customized African American | 11 Participants |
| Race/Ethnicity, Customized Asian or Pacific Islander | 4 Participants |
| Race/Ethnicity, Customized Caucasian | 18 Participants |
| Race/Ethnicity, Customized Hispanic | 4 Participants |
| Race/Ethnicity, Customized Native American | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants |
| Region of Enrollment United States | 40 participants |
| Sex: Female, Male Female | 22 Participants |
| Sex: Female, Male Male | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 0 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Sensitivity of INVSENSOR00027's Activity Change Detection
For each subject's activity (e.g., walking and upright) detection, INVSENSOR00027 output will be compared against observer's notes. Correctly detected activity changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's activity change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection).
Time frame: 1-5 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INVSENSOR00027 Test Group | Sensitivity of INVSENSOR00027's Activity Change Detection | 96.7 percent sensitivity for posture change |
Primary
Sensitivity of INVSENSOR00027's Fall Event Detection
Time frame: 1-5 hours
Population: Fall detection was an optional event per protocol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INVSENSOR00027 Test Group | Sensitivity of INVSENSOR00027's Fall Event Detection | 100 percent sensitivity for fall detection |
Primary
Sensitivity of INVSENSOR00027's Posture Change Detection
For each subject's position detection, INVSENSOR00027 output will be compared against observer's notes at each turn of the subject. Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00027's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection)
Time frame: 1-5 hours
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INVSENSOR00027 Test Group | Sensitivity of INVSENSOR00027's Posture Change Detection | 100 percent sensitivity for posture change |
Secondary
Respiratory Rate Detection
Accuracy will be determined by comparing the respiratory rate measurement of the INVSENSOR00027 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 INVSENSOR00027 RR 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
Population: 2 subjects were excluded due to data collection issues.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INVSENSOR00027 Test Group | Respiratory Rate Detection | 1.7 A(RMS) of breaths per minute |