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

NCT02265783 | Completed Results

• 1 other identifier: COVMOPR0461
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Healthy Volunteers

Keywords

Focus of Study: Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Nellcor USB Pulse Oximeter Monitor Interface Cable Sensor Test

OTHER

Device: Nellcor USB Pulse Oximeter Monitor Interface Cable

Interventions

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.

Nellcor USB Pulse Oximeter Monitor Interface Cable Sensor Test

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic - MITG: lead

Study Sites (1)

Boulder Clinical Laboratory

Boulder, Colorado, 80301, United States

Location

Results Point of Contact

• Title: Michael Luna-Victoria
• Organization: Medtronic

michael.luna-victoria@medtronic.com

3033052463

Study Officials

• Eric Heyer, MD

  Medtronic - MITG

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2014
• First Posted: October 16, 2014
• Study Start: September 1, 2014
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: May 1, 2017
• Results First Posted: May 1, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)