Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients

Nonin Medical

Status: Completed

Conditions: Respiratory Insufficiency

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03592914

QATP3161

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 1 patient group

subjects with respiratory disease

Description:

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).