Pulse Oximetry- Evaluating Sensor Off- PCBA-1
Sensor Off Studies Using a Bedside Respiratory Patient Monitoring System With the Multi-Functional Patient Monitoring PCBA-1
1 other identifier
observational
20
1 country
1
Brief Summary
To demonstrate that the sensor-off feature on the Pulse oximeter displays per specifications when the sensor is removed from the finger.
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 Sep 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
September 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
September 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)
Device posts Sensor Off within 1 minute after sensor is removed at least 90% of the time.
1-2 hours per subject
Eligibility Criteria
Healthy, Well Perfused subjects
You may qualify if:
- Male or female subjects 18 or older (inclusive).
- Subject is able to participate for the duration of the study
- Subject is willing to sign an informed consent
You may not qualify if:
- Previous injury or trauma to fingers or hands that may change blood flow or vascular supply and affect our ability to test sensors
- Physiologic abnormalities that prevent proper application of a medical sensor and electrode
- Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes
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
September 1, 2012
Primary Completion
September 1, 2012
Study Completion
September 1, 2012
Last Updated
December 6, 2013
Record last verified: 2013-12