INVSENSOR00013 Respiratory Rate Clinical Performance Study

Masimo

Status

Completed

Conditions

Healthy

Treatments

Device: INVSENSOR00013

Study type

Interventional

Funder types

Industry

Identifiers

NCT03440619

TP-18896

Details and patient eligibility

About

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.

Enrollment

28 patients

Sex

All

Ages

18 to 70 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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