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This is a validation study of a near-infrared spectroscopy (NIRS) device designed to measure the cerebral tissue oxygen saturation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Desaturation | Experimental | Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Desaturation | Device | The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%. |
| Measure | Description | Time Frame |
|---|---|---|
| Validated the Next Generation Oximeter | Cerebral overall mean bias (percentage saturation) defined as the average of the differences between the regional saturation (rSO2) value and (fSO2) value obtained from simultaneous arterial and jugular venous blood samples. Cerebral trending is defined as the measurement of changes in regional saturation (rSO2) under conditions of changing fSO2. Cerebral trending mean bias is the average difference between changes in rSO2 values compared against changes in fSO2. Somatic trending mean bias is defined the same as Cerebral trending mean bias except for the location of measurement on the subjects and for Somatic trending mean bias, rS02 was compared to rSO2 on a commercially-available regional oximetry monitor. The smaller value the better performance. | Data collected from individual participant over 4 hour timeframe. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julia Katilius | Medtronic | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital, HPPL | Durham | North Carolina | 27710 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Desaturation | Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%. Desaturation: The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Desaturation | Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%. Desaturation: The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Validated the Next Generation Oximeter | Cerebral overall mean bias (percentage saturation) defined as the average of the differences between the regional saturation (rSO2) value and (fSO2) value obtained from simultaneous arterial and jugular venous blood samples. Cerebral trending is defined as the measurement of changes in regional saturation (rSO2) under conditions of changing fSO2. Cerebral trending mean bias is the average difference between changes in rSO2 values compared against changes in fSO2. Somatic trending mean bias is defined the same as Cerebral trending mean bias except for the location of measurement on the subjects and for Somatic trending mean bias, rS02 was compared to rSO2 on a commercially-available regional oximetry monitor. The smaller value the better performance. | Posted | Mean | Standard Deviation | Percentage saturation | Data collected from individual participant over 4 hour timeframe. |
|
48 hours post study procedure (desaturation)
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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 | Desaturation | Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%. Desaturation: The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vasovagal episode | Nervous system disorders | MedDRA (17.0) | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Julia Katilius | Medtronic | 1 303-305-2278 | julia.z.katilius@medtronic.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 15, 2017 | Oct 12, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 18, 2017 | Oct 12, 2018 | SAP_001.pdf |
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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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|
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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Volunteers undergo oxygen desaturation in order to determine the accuracy of the device over a clinical range of oxygen saturations 70 - 100%.
Desaturation: The delivered gas mixture will be adjusted to decrease the displayed saturation of peripheral oxygen. Each desaturation steps are of approximately 5 minutes duration with reduction in pulse oximeter oxygen saturation from 100 to 70%.
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| 0 |
| 32 |
| 0 |
| 32 |
| 2 |
| 32 |
| Clavicular pain | Musculoskeletal and connective tissue disorders | MedDRA (17.0) | Systematic Assessment |
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