INVSENSOR00013 Respiratory Rate Clinical Performance Study

Completed · Not applicable

Conditions studied: Healthy

In brief

The objective of this prospective study is to compare the noninvasive respiration from pleth (RRp) performance of the Masimo INVSENSOR00013 device against the respiratory rate measured by capnography (RRref), Masimo's RAM technology and the manual annotation.

Key facts

Study ID: NCT03440619
Run by: Masimo Corporation
People needed: 28
Starts: 2018-02-06
Expected to finish: 2018-02-14
Last updated by the study team: 2019-04-23

Who can join

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

You may qualify if…

18 to 70 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, 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 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
Positive pregnancy test for female subjects
Refusal to take pregnancy test for women of child bearing potential
Nursing female subjects
Refusal of male subjects to agree to shave hair off areas where the sensor will be applied (neck) when deemed necessary
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 Clinical Lab — Irvine, California, United States

Full record on ClinicalTrials.gov

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