Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0

NCT ID: NCT02075398

Last Updated: 2014-03-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 35 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2013-12-31

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.

Conditions

Monitoring Arterial Oxygen Saturation

Study Design

• Observational Model Type: CASE_ONLY

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kelley Scott, MD

Role: PRINCIPAL_INVESTIGATOR

Medtronic - MITG

Locations

Boulder Clinical Laboratory

Boulder, Colorado, United States

Countries

United States

Other Identifiers

COVMOPR0428

Identifier Type: -

Identifier Source: org_study_id