Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients

Respiratory Insufficiency Clinical Trial

Official title:

Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592914
• Other study ID #: QATP3161
• Status: Completed
• Start date: July 31, 2018
• Est. completion date: January 16, 2019

Study information

• Verified date: March 2019
• Source: Nonin Medical, Inc
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 16, 2019
• Est. primary completion date: January 16, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pulmonary Valve Insufficiency
• Respiratory Insufficiency

Locations

Country	Name	City	State
United States	Nonin Medical, Inc.	Plymouth	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Nonin Medical, Inc	Valley Inspired Products

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate the two Fingertip Respiratory Rate (FTRR) algorithms performance of Nonin's Onyx 3	Measure respiratory rates	40 minutes