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| ID | Type | Description | Link |
|---|---|---|---|
| 2016-A01901-50 | Other Identifier | ANSM |
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Transcranial Doppler ultrasound (TCD) monitoring and CT-scanner perfusion are useful but imperfect tools to identify vasospasm and allow intervention to avoid infarction.
Permanent monitoring of cerebral tissue oximetry (rSO2) by NIRS, a noninvasive method could allow better vasospasm detection.
This study will evaluate diagnostic accuracy of cerebral oxymetry (NIRS) -by rSO2 measurement - in order to detect vasospasm in patient with severe subarachnoid hemorrhage compare to standard monitoring tools.
Delayed vasospasm is a serious complication of aneurismal subarachnoid haemorhage (SAH) significantly influencing morbidity and mortality. Mostly observed between days 4 and 10 after aneurismal rupture, its incidence is higher in cases of severe SAH. Vasospasm strongly affects prognisis generating delayed cerebral ischemia.
Clinical deterioration (focal neurological deficit) is the best way to detect severe vasospasm. Unfortunately, most of severe SAH are intubated and sedated prohibiting neurological evaluation. In these frequent situations, Transcranial Doppler (TCD), clinical and biological monitoring, CT-scanner (angio-CT and Perfusion-CT), MRI and cerebral angiography are routinely used to detect vasospasm. Yet, these tools have imperfect sensitivity and specificty delaying diagnosis and treatment.
Near-InfraRed Spectroscopy (NIRS) is a non-invasive method measuring tissue oxygenation by regional saturation of capillary-oxygenated hemoglobin (rSO2). This technology demonstrated ability to measure cerebral oxygenation and has previously been reported to monitor carotid and pediatric surgery. To date a few studies also reported NIRS monitoring feasability in post-SAH vasospasm. Our aim is here to evaluate NIRS monitoring for the diagnosis of vasospasm in severe SAH.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cerebral oxymetry monitoring (NIRS) | Experimental | Cerebral oxymetry (NIRS) -by rSO2 measurement - in order to detect vasospasm in patient with severe subarachnoid hemorrhage compare to standard monitoring tools |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebral oxymetry monitoring (NIRS) | Device | Near-InfraRed Spectroscopy (NIRS) is a non-invasive method measuring tissue oxygenation by regional saturation of capillary-oxygenated hemoglobin (rSO2). Starting on day 4 after aneurismal rupture NIRS electrods will be placed and maintained until day 12 permanently and blindly recording rSO2. Patients will be monitored following daily practice recommandations inclunding vasospasm detection and treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Permanent measurement of cerabral oxymetry (rSO2) by NIRS system | Difference between NIRS basal measurement entre la mesure basale du NIRS (NIRS average on the first hour of recording respectively on the left and right) and the NIRS measurement during the follow-up (lowest mean NIRS observed over one hour in patients without vasospasm diagnosed by the reference test or mean NIRS observed over the hour. | From day 4 to day 12 post aneurysmal subarachnoid hemorrhage |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of angiographic spasm | Not significant (<50%) Significant (>50%) Severe. | Day 8 post aneurysmal subarachnoid hemorrhage |
| Pti02 value | Pti02 value (mm Hg) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Bordeaux | Bordeaux | 33 076 | France |
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| ID | Term |
|---|---|
| D013345 | Subarachnoid Hemorrhage |
| ID | Term |
|---|---|
| D020300 | Intracranial Hemorrhages |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D019265 | Spectroscopy, Near-Infrared |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D013057 | Spectrum Analysis |
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|
| Day 4 post aneurysmal subarachnoid hemorrhage |
| Pti02 value | Pti02 value (mm Hg) | Day 8 post aneurysmal subarachnoid hemorrhage |
| Pti02 value | Pti02 value (mm Hg) | Day 12 post aneurysmal subarachnoid hemorrhage |
| D009422 | Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006470 | Hemorrhage |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002623 |
| Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |