INVSENSOR00027 Clinical Performance Study

Completed · Not applicable

Conditions studied: Healthy

In brief

This study assesses the investigational sensor's (INVSENSOR00027) performance for detection of subjects' position and posture in bed, along with heart rate and respiratory rate.

Key facts

Study ID

NCT03650192

Run by

Masimo Corporation

People needed

40

Starts

2018-08-15

Expected to finish

2018-09-18

Last updated by the study team

2021-01-29

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 to 80 years old
• Physical status of ASA I or II
• Subjects must be able to read and communicate in English
• Has signed all necessary related documents, e.g. written informed consent, volunteer payment form, confidentiality agreement
• Has completed Health Assessment Questionnaire and passed health assessment screening

You may not qualify if…

• Subject has any medical condition which in the judgment of the investigator, renders them inappropriate for participation in this 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 the pregnancy test (for female subjects)
• Positive pregnancy test for female subjects of child bearing potential. This is done for the safety of this population.
• Refusal to shave hair (neck, chest) off areas where sensors will be applied (male subjects)

Where it is running

• Masimo Clinical Lab — Irvine, California, United States

Full record on ClinicalTrials.gov

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