INVSENSOR00013 Respiratory Rate Clinical Performance Study
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Healthy
- Sponsor
- Masimo Corporation
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- RRp Arms of Sensor Accuracy
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
RRp Arms of Sensor Accuracy
Time Frame: 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.