Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients

Completed

• Conditions: Respiratory Insufficiency

• Registration Number: NCT03592914
• Lead Sponsor: Nonin Medical, Inc

Brief Summary

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

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 Timeline

• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-19
• Study Start: 2018-07-31
• Primary Completion: 2019-01-16
• Study Completion: 2019-01-16
• Status Verified: 2019-03
• Last Update Submitted: 2019-03-08
• Last Update Posted: 2019-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3	40 minutes	Measure respiratory rates

Trial Locations

Locations (1)

Nonin Medical, Inc.; 🇺🇸 Plymouth, Minnesota, United States