NCT01837537

Respiration Rate V2.0 in a Hospital Setting

Evaluation of Respiration Rate Parameters in a Hospital Population Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 90 (actual)
• Sponsor: Medtronic - MITG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR)(CO2).

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 any contact skin allergies to adhesives found in standard pulse oximetry sensors. A cross section of demographics - cardiovascular, respiratory, and metabolic type cases should be considered for a broad distribution of medical and surgical patients. The study consists of measuring parameters related to respiration in hospitalized volunteers by means of the Bedside Respiratory Patient Monitoring System with RR V2.0 (Nightingale). The production-equivalent Nightingale device and multiparameter reference devices will be attached to the subject via sensors, nasal cannulas and ECG leads and the information from all devices will be captured continuously for up to 40 minutes to allow for at least 30 minutes of artifact free data 30 minutes.

Conditions

• Respiratory Rate

Timeline

• Start date: 2013-03-01
• Primary completion: 2013-08-01
• Completion: 2013-10-01
• First posted: 2013-04-23
• Last updated: 2017-07-17
• Results posted: 2017-02-03

Locations

1 site across 1 country: United States