INVSENSOR00011 Clinical Performance Study

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 Overview

• Status: Terminated
• Conditions: Healthy
• Intervention / Treatment: Device: INVSENSOR00011

• Study Type: Interventional
• Enrollment (Actual): 10

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92618
      • Masimo Clinical Lab

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: INVSENSOR00011 Test group; The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor.	Device: INVSENSOR00011; INVSENSOR00011 - investigational sensor that will be placed on the subject's chest and/or back for the duration of the study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	Approximately 30 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Approximately 20 minutes

Collaborators and Investigators

• Sponsor: Masimo Corporation

Study record dates

Study Major Dates

• Study Start (Actual): July 23, 2018
• Primary Completion (Actual): July 24, 2018
• Study Completion (Actual): July 24, 2018

Study Registration Dates

• First Submitted: August 20, 2018
• First Submitted That Met QC Criteria: August 20, 2018
• First Posted (Actual): August 22, 2018

Study Record Updates

• Last Update Posted (Actual): January 3, 2022
• Last Update Submitted That Met QC Criteria: December 2, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: TP-19045A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No