INVSENSOR00013 Respiratory Rate Clinical Performance Study

Not Applicable

Completed

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
INVSENSOR00013 Test group	INVSENSOR00013	All subjects will be enrolled into the test group and will receive the INVSENSOR00013 investigational device.

Primary Outcome Measures

Name	Time	Method
RRp Arms of Sensor Accuracy	1-5 hours	Accuracy will be determined by comparing the noninvasive respiratory rate by pleth (RRp) measurement of the INVSENSOR00013 to the respiratory rate reference (RRef) and calculating the arithmetic root mean square (Arms) value. In order to obtain the Arms value, the RR measurement from the reference is subtracted from the INVSENSOR00013 RRp measurement for a number of samples. The average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the Arms value.

Secondary Outcome Measures