Pulse Oximetry- Evaluating Resp Rate- PCBA-1
Respiration Rate Parameter Studies in Healthy Volunteers Using a Bedside Respiratory Patient Monitoring System With the Multi-Functional Patient Monitoring PCBA-1
1 other identifier
observational
27
1 country
1
Brief Summary
To assess performance of resp rate parameter in a monitoring system PCBA-1
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Oct 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2012
CompletedFirst Submitted
Initial submission to the registry
November 29, 2012
CompletedFirst Posted
Study publicly available on registry
February 15, 2013
CompletedDecember 6, 2013
December 1, 2013
Same day
November 29, 2012
December 5, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
ME (mean error) of Respiration Rate values for each subject
1-2 hours per subject
Eligibility Criteria
Healthy Subjects
You may qualify if:
- Male or female subjects ages 18 or older.
- Subject is willing and able to provide written consent.
You may not qualify if:
- 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.
- Subjects with abnormalities that may prevent proper application of the device.
- 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 within thirty seconds).
- Women who are pregnant or lactating.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtronic - MITGlead
Study Sites (1)
Covidien
Boulder, Colorado, 80301, United States
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 29, 2012
First Posted
February 15, 2013
Study Start
October 1, 2012
Primary Completion
October 1, 2012
Study Completion
October 1, 2012
Last Updated
December 6, 2013
Record last verified: 2013-12