INVSENSOR00013 Respiratory Rate Clinical Performance Study
| Status: | Completed |
|---|---|
| Conditions: | Healthy Studies |
| Therapuetic Areas: | Other |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 2/1/2019 |
| Start Date: | February 6, 2018 |
| End Date: | February 14, 2018 |
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.
(RRp) performance of the Masimo INVSENSOR00013 device against the respiratory rate measured
by capnography (RRref), Masimo's RAM technology and the manual annotation.
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
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