Respiration Rate V2.0 in a Hospital Setting

Completed

Conditions studied: 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 hospitalized volunteer population when compared to established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR)(CO2).

Key facts

Study ID

NCT01837537

Run by

Medtronic - MITG

People needed

90

Starts

2013-03-01

Expected to finish

2013-10-01

Last updated by the study team

2017-07-17

Who can join

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

You may qualify if…

• Male or female.
• 18 years or older.
• A patient at the study site on a General Care Floor or General Surgery Care Floor.
• Subject is willing and able to provide written consent.

You may not qualify if…

• Subject is younger than 18.
• 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

• The Ohio State University Wexner Medical Center — Columbus, Ohio, United States

Full record on ClinicalTrials.gov

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