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| Name | Class |
|---|---|
| Duke University | OTHER |
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The purpose of the study is to calibrate and to validate the accuracy of the oximeter with an estimate of brain oxygen levels assessed by measuring arterial and internal jugular vein blood oxygen saturations.
The device is a non invasive NIRS monitor. It detects signals from which are derived venous and arterial blood brain oxygen levels.
The device will be used as a adjunct monitor in patients with a brain injury or at risk of a brain injury.
The primary objective of the study is to measure the absolute and relative accuracy of the StO2 device by comparing the NIRS-derived brain tissue oxygen saturation with blood-referenced CO-oximeter oxygen saturation values. The CO-oximeter oxygen saturation values from paired arterial and internal jugular venous blood gas samples are then inserted into a weighted-equation to derive the calculated brain tissue oxygen saturation. Accuracy is reported over a range of oxygen saturations with study subjects exposed to a controlled oxygen desaturation with serial sampling of paired arterial and internal jugular venous blood gas samples.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| desaturation | Experimental | Controlled desaturation studies are conducted by changing the alveolar oxygen tension (or pressure, PAO2). This is achieved by a dedicated gas delivery system, RespirAct RAMR (Thornhill Research, Toronto, ON). The attained PAO2 then determines the arterial oxygen tension (PaO2) at the alveolar-arterial interspace in the lung. The arterial oxygen tension (PaO2) will then determine the arterial oxygen saturation (SaO2) and in turn, the pulse oximeter oxygen saturation (SpO2). The step down changes in the alveolar oxygen tension (PAO2) will result in the corresponding step down changes in SaO2/SpO2 from 100 to 70%. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| brain pulse oximeter | Device | brain oxygen monitoring during hypoxia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of brain pulse oximeter | Bland Altman analysis | Data will be collected over a 90 minute period for each patient |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David MacLeod, MBBS | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Hospital Human Pharmacology & Physiology Lab | Durham | North Carolina | 27708 | United States |
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| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D000860 | Hypoxia |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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Single group assignment
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| D006259 |
| Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |