Status:
COMPLETED
INVSENSOR00013 Respiratory Rate Clinical Performance Study
Lead Sponsor:
Masimo Corporation
Conditions:
Healthy
Eligibility:
All Genders
18-70 years
Phase:
NA
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 14 2018
Estimated Enrollment :
28 Patients enrolled
Trial Details
Trial ID
NCT03440619
Start Date
February 6 2018
End Date
February 14 2018
Last Update
April 23 2019
Active Locations (1)
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1
Masimo Clinical Lab
Irvine, California, United States, 92618