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

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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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Device Feasibility
Condition Healthy Volunteers
Intervention Device: Nellcor USB Pulse Oximeter Monitor Interface Cable
Enrollment 20

Recruitment Details  
Pre-assignment Details  
Arm/Group Title The Oxicable Pulse Oximetry Device
Hide Arm/Group Description The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
Period Title: Overall Study
Started 20
Completed 20 [1]
Not Completed 0
[1]
All subjects completed, one excluded from the analysis due to an issue with the data collection
Arm/Group Title The Oxicable Pulse Oximetry Device
Hide Arm/Group Description The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
Overall Number of Baseline Participants 20
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
<=18 years
0
   0.0%
Between 18 and 65 years
20
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
Female
12
  60.0%
Male
8
  40.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 20 participants
American Indian or Alaska Native
0
   0.0%
Asian
2
  10.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
1
   5.0%
White
17
  85.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 20 participants
20
 100.0%
1.Primary Outcome
Title Report the Time Until the Device Posts "Sensor Off" After the Sensor is Removed
Hide Description 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.
Time Frame 1 minute per event, multiple events per subject. Total duration up to 1 hour
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
20 subjects participated. There were errors with the data collection device for one subject and the data was unusable.
Arm/Group Title The Oxicable Pulse Oximetry Device
Hide Arm/Group Description:
The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
Overall Number of Participants Analyzed 19
Mean (95% Confidence Interval)
Unit of Measure: Percent
98.7
(96.2 to 100)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title The Oxicable Pulse Oximetry Device
Hide Arm/Group Description The subjects sit in a chair while a pulse oximetry sensor, hooked to the Oxicable pulse oximeter and a data collection system, is placed and removed in a certain sequence. This is done to demonstrate that the sensor-off feature displays per specifications when subjected to certain simulated, sensor removal conditions known to represent challenges to the sensor-off feature.
All-Cause Mortality
The Oxicable Pulse Oximetry Device
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
The Oxicable Pulse Oximetry Device
Affected / at Risk (%)
Total   0/20 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
The Oxicable Pulse Oximetry Device
Affected / at Risk (%)
Total   0/20 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Michael Luna-Victoria
Organization: Medtronic
Phone: 3033052463
Responsible Party: Medtronic - MITG
ClinicalTrials.gov Identifier: NCT02265783     History of Changes
Other Study ID Numbers: COVMOPR0461
First Submitted: October 3, 2014
First Posted: October 16, 2014
Results First Submitted: March 21, 2017
Results First Posted: May 1, 2017
Last Update Posted: May 1, 2017