Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients

NCT ID: NCT03592914

Last Updated: 2019-03-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-07-31

Study Completion Date

2019-01-16

Brief Summary

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Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.

Detailed Description

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Study Design: This study is a comparative, single-center study. This is a minimal risk study (as defined in 21 CFR Part 56) using a non-significant risk device (as defined in 21 CFR Part 812.3). A minimum of 60 subjects will be enrolled in the study. Subject participation will last approximately 1 hour.

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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Respiratory Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

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 is at least 18 years old;
* 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 history of or current atrial fibrillation;
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Valley Inspired Products

UNKNOWN

Sponsor Role collaborator

Nonin Medical, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Nonin Medical, Inc.

Plymouth, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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QATP3161

Identifier Type: -

Identifier Source: org_study_id

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