INVSENSOR00027 Clinical Performance Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Masimo Corporation
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Sensitivity of INVSENSOR00027's Posture Change Detection
- Status
- Completed
- Last Updated
- 5 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
Outcomes
Primary Outcomes
Sensitivity of INVSENSOR00027's Posture Change Detection
Time Frame: 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
Time Frame: 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
Time Frame: 1-5 hours
Secondary Outcomes
- Respiratory Rate Detection(1-5 hours)