Healthy
Conditions
Brief summary
This study assesses the investigational sensor's (INVSENSOR00011) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.
Interventions
DEVICEINVSENSOR00011
INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study.
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 * Must be able to read and communicate in English * Has signed all necessary related documents, e.g. written informed consent, health assessment questionnaire, gender and ethnicity form, confidentiality agreement * Passed health assessment screening
Exclusion criteria
* 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 * Nursing female volunteers * Excluded at the Principal Investigator's discretion * Refusal to take pregnancy test (for female subjects) * Positive pregnancy tests for female subjects of child bearing potential. * Refusal to shave hair off areas where sensors will be applied (male subjects)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity of INVSENSOR00011's Posture Change Detection | Approximately 30 minutes | Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00011's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Respiratory Rate Detection | Approximately 20 minutes | When INVSENSOR00011 respiratory rate (RR) readings are available, it will be compared against reference respiratory rate by computing mean and standard deviation of the differences. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| INVSENSOR00011 Test Group The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor.
INVSENSOR00011: investigational sensor that will be placed on the subject's chest and/or back for the duration of the study. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | INVSENSOR00011 Test Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants |
| Race/Ethnicity, Customized Black or African American | 4 Participants |
| Race/Ethnicity, Customized Hispanic | 1 Participants |
| Race/Ethnicity, Customized Native American | 1 Participants |
| Race/Ethnicity, Customized White or Caucasian | 4 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 3 Participants |
| Sex: Female, Male Male | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Sensitivity of INVSENSOR00011's Posture Change Detection
Correctly detected position changes will be marked as True Positive. Missed detections (if any) will be counted. The sensitivity of INVSENSOR00011's posture change detection will be computed as Sensitivity = True Positive/(True Positive+Missed Detection)
Time frame: Approximately 30 minutes
Population: The protocol required a minimum of 30 subjects to sufficiently evaluate a detection sensitivity for INVSENSOR00011 sensor's posture change detection algorithm. The study was not able to meet this enrollment target and enrolled only 10 subjects, therefore data should be interpreted with caution due to the insufficient sample size. Across 10 enrolled subjects, there were 100 posture and activity related transitions observed (these include right, left, supine, upright and walking events).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| INVSENSOR00011 Test Group | Sensitivity of INVSENSOR00011's Posture Change Detection | 99 percent aggregate detection sensitivity |
Secondary
Respiratory Rate Detection
When INVSENSOR00011 respiratory rate (RR) readings are available, it will be compared against reference respiratory rate by computing mean and standard deviation of the differences.
Time frame: Approximately 20 minutes
Population: The protocol required a minimum of 30 subjects to sufficiently evaluate accuracy of the RR parameter. The study was not able to meet this enrollment target, therefore data should be interpreted with caution due to the insufficient sample size. An error analysis was carried out with reference measurements to assess INVSENSOR00011's RR accuracy. Across 10 enrolled subjects, the RR values from the device was compared against the reference RR to compute mean and standard deviation of bias (SDE).
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| INVSENSOR00011 Test Group | Respiratory Rate Detection | 3.64 breaths per minute | Standard Deviation 2.94 |