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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| no treatment | no treatment, prospective observational |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Volunteer subjects with no significant medical problems
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| Name | Affiliation | Role |
|---|---|---|
| Scott D Kelley, MD | Medtronic - MITG | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boulder In-House Clinical Laboratory | Boulder | Colorado | 80301 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | no Treatment | no treatment, prospective observational |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | no Treatment | no treatment, prospective observational |
| Units | Counts |
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| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | BrPM | up to 40 minutes of continous monitoring |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | no Treatment | no treatment, prospective observational |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Luna-Victoria | Medtronic | 303 305 2463 | michael.luna-victoria@medtronic.com |
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| Sex: Female, Male | Count of Participants | Participants |
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| Secondary | 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. | Posted | Mean | Standard Deviation | BrPM | up to 40 minutes of continuous monitoring |
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