Respiratory Rate Accuracy - Healthy Adults

Completed

Conditions studied: Normal Respiration Patterns

In brief

The objective of this study is to evaluate the Fingertip Respiratory Rate algorithm performance of the Nonin Medical X-100SP pulse oximetry systems with the 8300AA sensors and Onyx 3 fingertip oximeter. There is no treatment or interventions being performed.

Key facts

Study ID

NCT03223870

Run by

Nonin Medical, Inc

People needed

30

Starts

2017-07-11

Expected to finish

2017-07-31

Last updated by the study team

2017-08-02

Who can join

Age: 18 and older, up to 50. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• The subject is male or female
• The subject is of any racial or ethnic group
• The subject is > 30 kg (>66 pounds) in weight (based on measurement)
• The subject has at least one finger with a height of 0.3 - 1.0 inch (7.6 -25.4 mm) (based on measurement)
• The subject is between 18 years and 50 years of age (self-reported)
• 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 BMI greater than 30 (based on weight and height)
• The subject has a history of atrial fibrillation (self-reported)
• The subject has a documented history of frequent premature ventricular contractions (PVCs), defined as >3 per 30 seconds (self-reported)
• The subject has an implanted pacemaker (self-reported)
• 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 has a known respiratory condition (self-reported)
• The subject has a known heart or cardiovascular condition (self-reported)
• The subject is currently pregnant (self-reported)
• The subject is actively trying to get pregnant (self-reported)
• The subject is unwilling or unable to provide written informed consent to participate in the study
• The subject has another health condition which in the opinion of the principal investigator makes him/her unsuitable for testing.

Where it is running

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

Full record on ClinicalTrials.gov

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