Boulder Clinical Laboratory
Boulder, Colorado, 80301, United States
Completed
NCT Number: NCT02075398
Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0
To validate the Respiration Rate Version 2.0 algorithm, housed in the Nellcor Bedside Respiratory Patient Monitoring System, for performance during motion conditions.
Completed
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Conditions
Age range
18 year and older
Sex eligibility
All sexes
Study type
Observational
Primary location
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- Male or Female subjects 18 years or older (inclusive)
- Subject is able to participate for the duration of the study
- Subject is willing to sign an informed consent
Exclusion criteria
- Subject with abnormalities that may prevent proper application of the devices
- Physiologic abnormalities that prevent proper application of pulse oximetry sensor
- Severe contact allergies that cause a reaction to standard adhesive materials such as those fund in medical sensors and electrodes
- Subjects with significant arrhythmia, as determined by subject self-report during screening and I/E criteria assessment at study start. (Three events of irregularities in radial pulse with thirty seconds).
Treatment and study plan
Primary outcomes
-
To determine the respiration rate performance in healthy adult volunteers during motion when compared to established technologies for measuring parameters related to respiration.
Time frame: up to 3 months
Sponsors and collaborators
Lead sponsor
Medtronic - MITG
Industry
Registry information
Official study title
Evaluation of Respiration Rate Parameters During Motion in Healthy Volunteers Using a Nellcor Bedside Respiratory Patient Monitoring System With Respiration Rate Version 2.0
Important dates
- Study start
- 2013
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Mar 3, 2014
- Registry last updated
- Mar 3, 2014
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.