N/A
N=27
INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study
Healthy
Bottom Line
View on ClinicalTrials.gov: NCT03897179 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Mar 2020
Primary outcome: Primary: RRp Arms of Sensor Accuracy — 2.1 respiration per minute (RPM)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- INVSENSOR00032 and INVSENSOR00033 (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Masimo Corporation
- Primary completion
- Feb 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY RRp Arms of Sensor Accuracy |
2.1 | — |
Summary
This study compares the performance of respiration rate from pleth measured prospectively with either INVSENSOR00032 and/or INVSENSOR00033 devices against the respiration rate derived from the manual scoring of the capnography waveform in healthy adult subjects.
Eligibility Criteria
Inclusion Criteria
- 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 judgment of the investigator, renders them inappropriate for participation in this 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
- 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
Data sourced from ClinicalTrials.gov (NCT03897179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.