INVSENSOR00011 Clinical Performance Study

N/ATerminatedNCT03641937

Masimo Corporation10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

INVSENSOR00011DEVICE

INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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)

Locations (1)

Masimo Clinical Lab

Irvine, California, United States

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Data from ClinicalTrials.gov

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