Trial Outcomes & Findings for Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable (NCT NCT02265783)
NCT ID: NCT02265783
Last Updated: 2017-05-01
Results Overview
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.
COMPLETED
NA
20 participants
1 minute per event, multiple events per subject. Total duration up to 1 hour
2017-05-01
Participant Flow
Participant milestones
| Measure |
The Oxicable Pulse Oximetry Device
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.
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|---|---|
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Overall Study
STARTED
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20
|
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Overall Study
COMPLETED
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20
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Sensor Off Study Using a Nellcor USB Pulse Oximetry Monitor Interface Cable
Baseline characteristics by cohort
| Measure |
The Oxicable Pulse Oximetry Device
n=20 Participants
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.
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|---|---|
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Age, Categorical
<=18 years
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0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
20 Participants
n=99 Participants
|
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Age, Categorical
>=65 years
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0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=99 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
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0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=99 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
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Region of Enrollment
United States
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20 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: 1 minute per event, multiple events per subject. Total duration up to 1 hourPopulation: 20 subjects participated. There were errors with the data collection device for one subject and the data was unusable.
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.
Outcome measures
| Measure |
The Oxicable Pulse Oximetry Device
n=19 Participants
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.
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|---|---|
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Report the Time Until the Device Posts "Sensor Off" After the Sensor is Removed
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98.7 Percent
Interval 96.2 to 100.0
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Adverse Events
The Oxicable Pulse Oximetry Device
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place