Respiration Rate V2.0 in Healthy Volunteers

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Focus of the Study is Measuring Respiratory Rate

Participation Criteria
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Eligibility Criteria
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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 18. 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| no treatment<br>no treatment, prospective observational | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Error (ME) +/- 1 Breath Per Minute, RR Sensor | 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. | up to 40 minutes of continous monitoring | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ME +/- 1 Breath Per Minute, Max-N Sensor | The software shall calculate respiration rate values via Max-N with a mean error of +/- 1 breath per minute relative to a capnography based reference. | up to 40 minutes of continuous monitoring |