Bedside Respiratory Patient Monitoring System - Sensor Off Study
Completed
- Conditions
- Healthy Volunteers
- Registration Number
- NCT02075346
- Lead Sponsor
- Medtronic - MITG
- Brief Summary
Use of an investigational oximetry system to evaluate the triggering of the "sensor off" status with the marketed off-the-shelf sensors.
- Detailed Description
The Multi-functional Patient Monitoring PCBA is an electronic circuit board in the monitoring system that performs calculations.
The study will evaluate the performance of the Sensor Off New Patient Monitoring system by exposing the sensor to an ambient light source, sensor slipping off the finger with the light emitter and detector facing each other or a sensor slipping off under a blanket.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18
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
- 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 pulse oximetry sensor.
- Severe contact allergies that cause a reaction to standard adhesive materials such as those found in medical sensors and electrodes
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To validate that the device posts a "Sensor Off" message within one minute after the sensor is removed at least ninety percent of the time. The planned duration of the study is 1 month.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Boulder Clinical Laboratory
🇺🇸Boulder, Colorado, United States