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INVSENSOR00013 Respiratory Rate Clinical Performance Study

NCT03440619 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2019-04-23

Study results available
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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.

Conditions

  • Healthy

Interventions

DEVICE

INVSENSOR00013

Investigational pulse oximeter device that will be placed on the subject's finger. This will be used as a spotcheck device

Sponsors & Collaborators

  • Masimo Corporation

    lead INDUSTRY

Principal Investigators

  • Ahmed Alghazi, M.D. · Masimo Corporation

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
2018-02-06
Primary Completion
2018-02-14
Completion
2018-02-14
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03440619 on ClinicalTrials.gov