Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0

Completed

• Conditions: Monitoring Arterial Oxygen Saturation

• Registration Number: NCT02075398
• Lead Sponsor: Medtronic - MITG

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2013-12
• Study Start: 2013-12
• Primary Completion: 2013-12
• Study Completion: 2013-12
• Study First Submitted: 2014-02-27
• Study First Submitted QC: 2014-02-27
• Last Update Submitted: 2014-02-27
• Study First Posted: 2014-03-03
• Last Update Posted: 2014-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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).

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine the respiration rate performance in healthy adult volunteers during motion when compared to established technologies for measuring parameters related to respiration.	up to 3 months

Trial Locations

Locations (1)

Boulder Clinical Laboratory; 🇺🇸 Boulder, Colorado, United States