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Trial record 23 of 72 for:    oximeter | Studies With Results

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02265783
Recruitment Status : Completed
First Posted : October 16, 2014
Results First Posted : May 1, 2017
Last Update Posted : May 1, 2017
Sponsor:
Information provided by (Responsible Party):
Medtronic - MITG

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.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Device: Nellcor USB Pulse Oximeter Monitor Interface Cable Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable
Study Start Date : September 2014
Actual Primary Completion Date : November 2014
Actual Study Completion Date : November 2014

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02265783


Locations
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United States, Colorado
Boulder Clinical Laboratory
Boulder, Colorado, United States, 80301
Sponsors and Collaborators
Medtronic - MITG
Investigators
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Principal Investigator: Eric Heyer, MD Medtronic - MITG

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Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT02265783     History of Changes
Other Study ID Numbers: COVMOPR0461
First Posted: October 16, 2014    Key Record Dates
Results First Posted: May 1, 2017
Last Update Posted: May 1, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data will not be shared.

Keywords provided by Medtronic - MITG:
Focus of Study: Healthy Volunteers