Respiration Rate V2.0 in Healthy Volunteers

Completed

Conditions studied: Focus of the Study is Measuring Respiratory Rate

In brief

The purpose of this study is to meet the respiration rate accuracy specifications for the study pulse oximeter monitoring system (study device)in a healthy volunteer population when compared to established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR) (CO2).

Key facts

Study ID

NCT01804062

Run by

Medtronic - MITG

People needed

30

Starts

2013-02-01

Expected to finish

2013-02-01

Last updated by the study team

2015-08-10

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Male or female subjects.
• 18 years or older.
• Subject is willing and able to provide written consent.

You may not qualify if…

• Subject is younger than 18.
• Subject is pregnant or lactating
• Subject has severe contact allergies that may cause a reaction to standard adhesive materials found in pulse oximetry sensors, ECG electrodes, respiration monitor electrodes or other medical sensors.
• Subject has an abnormality that may prevent proper application of the device.
• Subject is in atrial fibrillation.
• Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds
• Subject has an implanted pacemaker.
• Subject is unwilling or unable to sign informed consent.

Where it is running

• Boulder In-House Clinical Laboratory — Boulder, Colorado, United States

Full record on ClinicalTrials.gov

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