INVSENSOR00011 Clinical Performance Study

Terminated

• Conditions: Healthy
• Interventions: Device: INVSENSOR00011

• Registration Number: NCT03641937
• Lead Sponsor: Masimo Corporation

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-23
• Primary Completion: 2018-07-24
• Study Completion: 2018-07-24
• Study First Submitted: 2018-08-20
• Study First Submitted QC: 2018-08-20
• Study First Posted: 2018-08-22
• Disposition First Submitted: 2019-08-05
• Results First Submitted: 2021-07-30
• Status Verified: 2021-12
• Results First Submitted QC: 2021-12-02
• Disposition First Submitted QC: 2021-12-02
• Last Update Submitted: 2021-12-02
• Results First Posted: 2022-01-03
• Disposition First Posted: 2022-01-03
• Last Update Posted: 2022-01-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
INVSENSOR00011 Test group	INVSENSOR00011	The subjects will be enrolled into the test group and will receive the INVSENSOR00011 investigational sensor.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Masimo Clinical Lab; 🇺🇸 Irvine, California, United States