Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients

Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Insufficiency

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 Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Plymouth, Minnesota, United States, 55441
      • Nonin Medical, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Subjects who might be seen in a respiratory rehabilitation center.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
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).

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Nonin Medical, Inc
• Collaborators: Valley Inspired Products

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2018
• Primary Completion (Actual): January 16, 2019
• Study Completion (Actual): January 16, 2019

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): March 12, 2019
• Last Update Submitted That Met QC Criteria: March 8, 2019
• Last Verified: March 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: QATP3161

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No