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NCT03440619 · ClinicalTrials.gov registry record · NA
INVSENSOR00013 Respiratory Rate Clinical Performance Study
A NA study, sponsored by Masimo Corporation.
- Completed
- Registry status
- NA
- Development phase
- 28
- Enrollment target
NCT03440619: Completed NA study, sponsored by Masimo Corporation.
NCT03440619 is a NA study that has completed, run by Masimo Corporation. The registered enrollment target is 28 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03440619, a NA study, has completed, sponsored by Masimo Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 28 participants
- Enrollment target
Study 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.
Primary Outcome
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 preci
Interventions
- DEVICE INVSENSOR00013
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 28 participants |
| Start Date | 2018-02-06 |
| Est. Completion | 2018-02-14 |
| Phase | NA |
What the finished NCT03440619 record still lists
NCT03440619 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 28 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which INVSENSOR00013 is the first listed.
NCT03440619 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03440619 about?
NCT03440619 is a clinical study titled "INVSENSOR00013 Respiratory Rate Clinical Performance Study". 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.
What is the current status of trial NCT03440619?
This trial is currently completed. It is a NA study. The enrollment target is 28 participants. The study started on 2018-02-06. Estimated completion is 2018-02-14.
What interventions are being tested in trial NCT03440619?
The interventions under investigation include: INVSENSOR00013 (DEVICE).
Who is sponsoring clinical trial NCT03440619?
This trial is sponsored by Masimo Corporation, which has 96 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03440619's enrollment target sits among peer trials
28 1704th of 2000 higher than 293 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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