INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study

Completed · Not applicable

Conditions studied: Healthy

In brief

This study compares the performance of respiration rate from pleth measured prospectively with either INVSENSOR00032 and/or INVSENSOR00033 devices against the respiration rate derived from the manual scoring of the capnography waveform in healthy adult subjects.

Key facts

Study ID

NCT03897179

Run by

Masimo Corporation

People needed

27

Starts

2019-02-13

Expected to finish

2019-02-25

Last updated by the study team

2020-03-27

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 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, confidentiality agreement.
• Passed health assessment screening
• Negative pregnancy test for female subjects of child bearing potential.

You may not qualify if…

• Physical status of ASA III, IV, or V
• 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
• Positive pregnancy test for female subjects
• Refusal to take pregnancy test for women of child bearing potential
• Nursing female subjects
• Subjects wearing acrylic nails or subjects refusing to remove nail polish
• Subjects who have a nail deformity on the measurement finger
• Subjects who do not have adequate skin integrity on the measurement finger
• Excluded at the Principal Investigator's discretion

Where it is running

• Masimo Corporation — Irvine, California, United States

Full record on ClinicalTrials.gov

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