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OpenTrials
Completed

NCT Number: NCT02075346

Bedside Respiratory Patient Monitoring System - Sensor Off Study

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

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Boulder Clinical Laboratory

Boulder, Colorado, 80301, United States

About this study

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.

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

  • 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

Treatment and study plan

Primary outcomes

  1. 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.

    Time frame: The planned duration of the study is 1 month.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Official study title

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

Acronym: BRPMS

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.

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