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To validate the proposed claims for pulse rate and saturation accuracy in a diverse subject population during motion over a specified saturation range.
Use an investigational oximetry system to evaluate the triggering of the "sensor off" status with marketed, off-the-shelf sensors.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arterial Line | Experimental | CO-Oximetry value obtained as a comparator. Obtained during motion conditions. |
|
| Motion | Experimental | The subject has to perform motions during the procedure. This is to verify that device is able to read through motion. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arterial line | Device | Arterial line is inserted to draw a CO-Oximeter value as it is the gold standard and as advised in ISO 80601 |
|
| Measure | Description | Time Frame |
|---|---|---|
| SpO2 Accuracy During Motion Conditions - MaxA Sensor | For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit. | up to 6 months |
| SpO2 Accuracy During Motion Conditions - MaxN Sensor | For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit. | up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| 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 | ||
| Covidien RMS |
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| ID | Title | Description |
|---|---|---|
| FG000 | USB Pulse Oximetry Monitor Interface Cable | Additional interventions include the following: Radial Arterial Line placement involves introduction of a standard arterial catheter or angiocath into the radial artery. Since the arterial catheter is placed into the artery using a needle, there will be mild to moderate discomfort. The total amount of blood drawn during the procedure is less than 100cc. Additionally, subjects are asked to perform motions with their hand. Standard motions include tapping and rubbing at aperiodic intervals with amplitudes of 1-2 cm and 1-4 Hz with a random variation in frequency. The subject is instructed to tap (or rub) with finger tips to maintain consistency of area of effect on the pressure pad and to prevent resting hand on pressure pad between motions so that only qualified taps are recorded by the pressure pad system. Each plateau will have both an interval of tapping and rubbing. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | no Treatment |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | SpO2 Accuracy During Motion Conditions - MaxA Sensor | For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxA sensors has a different bandage from the MaxN sensor, and therefore a different form and fit. | Posted | Number | Accuracy Root Mean Square | up to 6 months |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | no Treatment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| mild IV infiltration | Skin and subcutaneous tissue disorders |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Michael Luna-Victoria | Medtronic | 3034068955 | michael.luna-victoria@medtronic.com |
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| ID | Term |
|---|---|
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D062666 | Vascular Access Devices |
| ID | Term |
|---|---|
| D057785 | Catheters |
| D004864 | Equipment and Supplies |
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| Motion | Device | The subject is asked to move their hand by either rubbing or tapping their fingers at a specified frequency and amplitude during portions of the hypoxic procedure. |
|
| Boulder |
| Colorado |
| 80301 |
| United States |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | SpO2 Accuracy During Motion Conditions - MaxN Sensor | For each range specified, SpO2 accuracy of the pulse oximeter equipment is stated in terms of the Accuracy Root-Mean-Square (ARMS) difference between measured values (SpO2) and reference blood values (SaO2). The MaxN sensor has a different bandage from the MaxA sensor, and therefore a different form and fit. | Posted | Number | Accuracy Root Mean Square | up to 6 months |
|
|
|
| 0 |
| 18 |
| 1 |
| 18 |
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