NCT03641937TerminatedNot Applicable
INVSENSOR00011 Clinical Performance Study
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Masimo Corporation
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Sensitivity of INVSENSOR00011's Posture Change Detection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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)
Arms & Interventions
INVSENSOR00011 Test group
Experimental
The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor.
Intervention: INVSENSOR00011 (Device)
Outcomes
Primary Outcomes
Sensitivity of INVSENSOR00011's Posture Change Detection
Time Frame: 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 Outcomes
- Respiratory Rate Detection(Approximately 20 minutes)
Investigators
Study Sites (1)
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