Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients
NCT ID: NCT03592914
Last Updated: 2019-03-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
60 participants
OBSERVATIONAL
2018-07-31
2019-01-16
Brief Summary
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Detailed Description
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Objective(s):
The primary objective of this study is to evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3 by attempting to demonstrate a mean error for FTRR \< 1.0 BPM during spontaneous breathing.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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subjects with respiratory disease
This study is a comparative, single-center study. This is a minimal risk study using a non-significant risk device. A minimum of 60 and maximum of 70 subjects will be enrolled in the study. Subject participation will last approximately 1 hour(s).
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* The subject has given written informed consent to participate in the study;
* The subject is both willing and able to comply with study procedures.
Exclusion Criteria
* The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as \>3 per 30 seconds;
* The subject has an implanted pacemaker;
* The subject has had any relevant injury at the sensor location site (self-reported);
* The subject has deformities or abnormalities that may prevent proper application of the device under test (based on examination);
* The subject is currently or trying to get pregnant (self-reported); and/or
* The subject has another health condition which in the opinion of the principal investigator makes subject unsuitable for testing.
18 Years
ALL
No
Sponsors
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Valley Inspired Products
UNKNOWN
Nonin Medical, Inc
INDUSTRY
Responsible Party
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Locations
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Nonin Medical, Inc.
Plymouth, Minnesota, United States
Countries
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Other Identifiers
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QATP3161
Identifier Type: -
Identifier Source: org_study_id
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