Evaluation of Respiration Rate Parameters in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Focus of the Study is Measuring Respiratory Rate
- Sponsor
- Medtronic - MITG
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor
- Status
- Completed
- Last Updated
- 10 years ago
Overview
Brief 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 healthy volunteer population when compared to established technologies for measuring parameters related to respiration, such as Capnograph Respiration Rate (RR) (CO2).
Detailed Description
Volunteer subjects with no significant medical problems (see specific inclusion/exclusion criteria) over the age of 18, male and female, who provide written informed consent prior to the procedure, are not pregnant, and without any contact skin allergies to adhesives found in standard pulse oximetry sensors. The study consists of measuring parameters related to respiration in healthy volunteers by means of the Bedside Respiratory Patient Monitoring System with RR V2.0 (Nightingale). The prototype 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female subjects.
- •18 years or older.
- •Subject is willing and able to provide written consent.
Exclusion Criteria
- •Subject is younger than
- •Subject is pregnant or lactating
- •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.
- •Subject has an abnormality that may prevent proper application of the device.
- •Subject is in atrial fibrillation.
- •Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds
- •Subject has an implanted pacemaker.
- •Subject is unwilling or unable to sign informed consent.
Outcomes
Primary Outcomes
Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor
Time Frame: up to 40 minutes of continous monitoring
The software shall calculate respiration rate values via Adult Respiratory Sensor with a mean error of +/- 1 breath per minute relative to a capnography based reference.
Secondary Outcomes
- ME +/- 1 Breath Per Minute, Max-N Sensor(up to 40 minutes of continuous monitoring)