Boulder In-House Clinical Laboratory
Boulder, Colorado, 80301, United States
NCT Number: NCT01804062
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Observational
Boulder, Colorado, 80301, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
Medtronic - MITG
Industry
Evaluation of Respiration Rate Parameters in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT01881269
Focus of the Study is Measuring Respiratory Rate
Columbus, Ohio, United States
View Trial Details