Respiration Rate Parameter Studies in Healthy Volunteers Using a Bedside Respiratory Patient Monitoring System With the Multi-Functional Patient Monitoring PCBA-1

Medtronic - MITG1 site in 1 country27 target enrollmentOctober 2012

Overview

Phase: N/A
Intervention: Not specified
Conditions: Healthy Subjects
Sponsor: Medtronic - MITG
Enrollment: 27
Locations: 1
Primary Endpoint: ME (mean error) of Respiration Rate values for each subject
Status: Completed
Last Updated: 12 years ago

To assess performance of resp rate parameter in a monitoring system PCBA-1

Registry

clinicaltrials.gov

Start Date

October 2012

End Date

October 2012

Last Updated

12 years ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•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.
•Subjects with abnormalities that may prevent proper application of the device.
•Subjects with significant Arrhythmia, as determined by subject self-report during screening and I/E criteria assessment at study start. (Three events of irregularities in radial pulse within thirty seconds).
•Women who are pregnant or lactating.