Status:
COMPLETED
Respiration Rate V2.0 in a Hospital Setting
Lead Sponsor:
Medtronic - MITG
Conditions:
Respiratory Rate
Eligibility:
All Genders
18+ years
Brief Summary
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 ...
Detailed Description
Volunteer subjects from a hospital setting (see specific inclusion/exclusion criteria) over the age of 18, male and female, who provide written informed consent prior to the procedure, and are without...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
March 1 2013
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2013
Estimated Enrollment :
90 Patients enrolled
Trial Details
Trial ID
NCT01837537
Start Date
March 1 2013
End Date
October 1 2013
Last Update
July 17 2017
Active Locations (1)
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1
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210