INVSENSOR00013 Respiratory Rate Clinical Performance Study

Study Overview
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Brief Summary
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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.

Official Title
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INVSENSOR00013 Respiratory Rate Clinical Performance Study

Conditions
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Healthy

Intervention / Treatment
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* Device: INVSENSOR00013


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INVSENSOR00013 Test group<br>All subjects will be enrolled into the test group and will receive the INVSENSOR00013 investigational device. | Device: INVSENSOR00013<br>* Investigational pulse oximeter device that will be placed on the subject's finger. This will be used as a spotcheck device<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RRp Arms of Sensor Accuracy | 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. | 1-5 hours |