Evaluation of Respiration Rate Parameters During Motion in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0

Medtronic - MITG1 site in 1 country35 target enrollmentDecember 2013

ConditionsMonitoring Arterial Oxygen Saturation

Overview

Phase: N/A
Intervention: Not specified
Conditions: Monitoring Arterial Oxygen Saturation
Sponsor: Medtronic - MITG
Enrollment: 35
Locations: 1
Primary Endpoint: To determine the respiration rate performance in healthy adult volunteers during motion when compared to established technologies for measuring parameters related to respiration.
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

To validate the Respiration Rate Version 2.0 algorithm, housed in the Nellcor Bedside Respiratory Patient Monitoring System, for performance during motion conditions.

Registry

clinicaltrials.gov

Start Date

December 2013

End Date

December 2013

Last Updated

12 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Medtronic - MITG

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Male or Female subjects 18 years or older (inclusive)
•Subject is able to participate for the duration of the study
•Subject is willing to sign an informed consent

Exclusion Criteria

•Subject with abnormalities that may prevent proper application of the devices
•Physiologic abnormalities that prevent proper application of pulse oximetry sensor
•Severe contact allergies that cause a reaction to standard adhesive materials such as those fund in medical sensors and electrodes
•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 with thirty seconds).

Outcomes

Primary Outcomes

To determine the respiration rate performance in healthy adult volunteers during motion when compared to established technologies for measuring parameters related to respiration.

Time Frame: up to 3 months