Healthy Volunteers
Conditions
Keywords
Focus of Study: Healthy Volunteers
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.
Interventions
DEVICENellcor 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.
Sponsors
Medtronic - MITG
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Report the Time Until the Device Posts Sensor Off After the Sensor is Removed | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | The Oxicable Pulse Oximetry Device |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 20 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 2 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 17 Participants |
| Region of Enrollment United States | 20 Participants |
| Sex: Female, Male Female | 12 Participants |
| Sex: Female, Male Male | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
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.
Time frame: 1 minute per event, multiple events per subject. Total duration up to 1 hour
Population: 20 subjects participated. There were errors with the data collection device for one subject and the data was unusable.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| The Oxicable Pulse Oximetry Device | Report the Time Until the Device Posts Sensor Off After the Sensor is Removed | 98.7 Percent |