Sensor Off Study Using a Nellcor USB Pulse Oximetry Monit... | NCT02265783

NCT02265783

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Description Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Nellcor USB Pulse Oximeter Monitor Interface Cable Sensor Test	Other		Device: Nellcor USB Pulse Oximeter Monitor Interface Cable

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Contacts/Locations Module

Name	Affiliation	Role
Eric Heyer, MD	Medtronic - MITG	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Boulder Clinical Laboratory		Boulder	Colorado	80301	United States

IPD Sharing Statement Module

Arm/Group Information

ID	Title	Description
FG000	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.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00020 subjects
COMPLETED		FG00020 subjectsAll subjects completed, one excluded from the analysis due to an issue with the data collection
NOT COMPLETED		FG0000 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	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.

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical			Count of Participants

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

20 subjects participated. There were errors with the data collection device for one subject and the data was unusable.

Posted

Mean

95% Confidence Interval

Percent

1 minute per event, multiple events per subject. Total duration up to 1 hour

ID	Title	Description
OG000	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.

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.

More Info Module

Certain Agreements