Respiration Rate V2.0 in Healthy Volunteers
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|ClinicalTrials.gov Identifier: NCT01804062|
Recruitment Status : Completed
First Posted : March 5, 2013
Results First Posted : August 10, 2015
Last Update Posted : August 10, 2015
|Condition or disease|
|Focus of the Study is Measuring Respiratory Rate|
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.
|Study Type :||Observational|
|Actual Enrollment :||30 participants|
|Official Title:||Evaluation of Respiration Rate Parameters in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0|
|Study Start Date :||February 2013|
|Actual Primary Completion Date :||February 2013|
|Actual Study Completion Date :||February 2013|
no treatment, prospective observational
- 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.
- ME +/- 1 Breath Per Minute, Max-N Sensor [ Time Frame: up to 40 minutes of continuous monitoring ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01804062
|United States, Colorado|
|Boulder In-House Clinical Laboratory|
|Boulder, Colorado, United States, 80301|
|Principal Investigator:||Scott D Kelley, MD||Medtronic - MITG|