INVSENSOR00011 Clinical Performance Study

Healthy Clinical Trial

Official title:

INVSENSOR00011 Clinical Performance Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03641937
• Other study ID #: TP-19045A
• Status: Terminated
• Start date: July 23, 2018
• Est. completion date: July 24, 2018

Study information

• Verified date: December 2021
• Source: Masimo Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 10
• Est. completion date: July 24, 2018
• Est. primary completion date: July 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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)

Related Conditions & MeSH terms

• Healthy

Intervention

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

Locations

Country	Name	City	State
United States	Masimo Clinical Lab	Irvine	California

Sponsors (1)

Lead Sponsor	Collaborator
Masimo Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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