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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: Nellcor USB Pulse Oximeter Monitor Interface Cable

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

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 to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Nellcor USB Pulse Oximeter Monitor Interface Cable Sensor Test	Device: Nellcor USB Pulse Oximeter Monitor Interface Cable; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Report the Time Until the Device Posts "Sensor Off" After the Sensor is Removed	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.	1 minute per event, multiple events per subject. Total duration up to 1 hour

Collaborators and Investigators

• Sponsor: Medtronic - MITG
• Investigators: Principal Investigator: Eric Heyer, MD, Medtronic - MITG

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: October 3, 2014
• First Submitted That Met QC Criteria: October 10, 2014
• First Posted (Estimate): October 16, 2014

Study Record Updates

• Last Update Posted (Actual): May 1, 2017
• Last Update Submitted That Met QC Criteria: March 21, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Focus of Study: Healthy Volunteers
• Other Study ID Numbers: COVMOPR0461

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The data will not be shared.