Bedside Respiratory Patient Monitoring System - Sensor Off Study (BRPMS)

Sensor Off Studies Using a Nellcor Bedside Respiratory Patient Monitoring System, Configured With the Multi-functional Respiratory PCBA

Use of an investigational oximetry system to evaluate the triggering of the "sensor off" status with the marketed off-the-shelf sensors.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers

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.

• Study Type: Observational
• Enrollment (Actual): 18

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Boulder, Colorado, United States, 80301
      • Boulder Clinical Laboratory

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Up to 20 subjects recruited from the Clinical Laboratory subject data base.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Scott Kelley, MD, Medtronic - MITG

Study record dates

Study Major Dates

• Study Start: November 1, 2013
• Primary Completion (Actual): November 1, 2013
• Study Completion (Actual): November 1, 2013

Study Registration Dates

• First Submitted: February 27, 2014
• First Submitted That Met QC Criteria: February 27, 2014
• First Posted (Estimate): March 3, 2014

Study Record Updates

• Last Update Posted (Estimate): March 3, 2014
• Last Update Submitted That Met QC Criteria: February 27, 2014
• Last Verified: December 1, 2013

More Information

Terms related to this study

• Keywords: Patient safety monitors
• Other Study ID Numbers: COVMOPR0419