Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable

The purpose of this study is to validate that the device posts a Sensor-Off message within the time frame stated in the proposed claims.

Completed

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Key information

Conditions

Healthy Volunteers

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boulder Clinical Laboratory

Boulder, Colorado, 80301, United States

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 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

Nellcor USB Pulse Oximeter Monitor Interface Cable

Device

Volunteers are subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature. Such conditions include 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.

Primary outcomes

Report the Time Until the Device Posts "Sensor Off" After the Sensor is Removed

Time frame: 1 minute per event, multiple events per subject. Total duration up to 1 hour

A series of sensor-off events were collected from subjects in the study using marketed, off-the-shelf sensors. Each event was marked as pass if event duration (Timeend - Timestart) was less than or equal to 60 seconds; otherwise, the event was marked as greater than or equal to 60 seconds. The acceptance criteria is if 90% of the time the product posts Sensor Off, or any equal or higher priority alarm, within 60 seconds after sensor is removed.

Sponsors and collaborators

Lead sponsor

Medtronic - MITG

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Oct 16, 2014
Registry last updated: May 1, 2017

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.

Published trials that share one or more normalized conditions with this study.

Completed