Respiratory Rate Accuracy Verification Clinical: Pulmonary Rehabilitation Patients

Completed

Conditions studied: Respiratory Insufficiency

In brief

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.

Key facts

Study ID

NCT03592914

Run by

Nonin Medical, Inc

People needed

60

Starts

2018-07-31

Expected to finish

2019-01-16

Last updated by the study team

2019-03-12

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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