INVSENSOR00032 and INVSENSOR00033 Respiration Rate Clinical Performance Study
NCT03897179 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27
Last updated 2020-03-27
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.
Conditions
- Healthy
Interventions
- DEVICE
-
INVSENSOR00032 and INVSENSOR00033
Investigational pulse oximeter device
Sponsors & Collaborators
-
Masimo Corporation
lead INDUSTRY
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2019-02-13
- Primary Completion
- 2019-02-25
- Completion
- 2019-02-25
- FDA Device
- Yes
Countries
- United States
Study Locations
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