Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

Tracking Information
First Submitted Date  ICMJE October 3, 2014
First Posted Date  ICMJE October 16, 2014
Results First Submitted Date  ICMJE March 21, 2017
Results First Posted Date  ICMJE May 1, 2017
Last Update Posted Date May 1, 2017
Study Start Date  ICMJE September 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 21, 2017)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 10, 2014)
Device posts Sensor Off within 1 minute after sensor is removed at least 90% of the time. [ Time Frame: 1-2 hours per subject ] [ Time Frame: 1 minute ]
Change History Complete list of historical versions of study NCT02265783 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable
Official Title  ICMJE Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Condition  ICMJE Healthy Volunteers
Intervention  ICMJE 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.
Study Arms  ICMJE Nellcor USB Pulse Oximeter Monitor Interface Cable Sensor Test
Intervention: Device: Nellcor USB Pulse Oximeter Monitor Interface Cable
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2014)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2014
Actual Primary Completion Date November 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02265783
Other Study ID Numbers  ICMJE COVMOPR0461
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: The data will not be shared.
Responsible Party Medtronic - MITG
Study Sponsor  ICMJE Medtronic - MITG
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Eric Heyer, MD Medtronic - MITG
PRS Account Medtronic - MITG
Verification Date March 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP