Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients

Nonin Medical, Inc60 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Respiratory Insufficiency

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Nonin Medical, Inc.

Plymouth, Minnesota, United States

Outcomes

Primary Outcomes

Evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3

Measure respiratory rates

Time frame: 40 minutes

Data from ClinicalTrials.gov

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