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| ID | Type | Description | Link |
|---|---|---|---|
| AOI... | Other Grant/Funding Number | CHU Clermont-Ferrand |
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Acute ischemic stroke due to large vessel occlusion is responsible of cerebral blood flow impairment with a progressive and extensive ischemic process. Cerebral collateral circulation may preserve an ischemic penumbra that could recover providing timely reperfusion of the occluded vessel. Mechanical thrombectomy is the standard of care for anterior circulation large vessel reperfusion. Strategy to promote cerebral blood flow in collateral circulation before reperfusion is scarce and rely mainly on blood pressure maintenance. Carbon dioxide is a potent cerebral vasodilator that could enhance collateral circulation blood flow and cerebral protection before reperfusion. General anesthesia with endotracheal mechanical ventilation could be used for thrombectomy and give the opportunity to modulate and control carbon dioxide tension in the blood. This study will test the effect of moderate hypercapnia on penumbral collateral circulation before reperfusion during mechanical thrombectomy for anterior circulation acute ischemic stroke under general anesthesia.
Study will compare 2 groups of patients treated for anterior circulation large vessel occlusion stroke thrombectomy under general anesthesia.
After anesthetic evaluation, patients will be randomized to receive moderate hypercapnia targeting an arterial CO2 tension (PaCO2) of 50mmHg or normocapnia targeting a PaCO2 of 40mmHg.
The anesthetic protocol will use:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HYPERCAPNIA | Experimental | Under general anesthesia with mechanical ventilation, PaCO2=50mmHg will be targeted |
|
| NORMOCAPNIA | Active Comparator | Under general anesthesia with mechanical ventilation, PaCO2=40mmHg will be targeted |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HYPERCAPNIA | Biological | Controlled moderate hypercapnia PaCO2 50mmHg under general anesthesia with mechanical ventilation |
|
| Measure | Description | Time Frame |
|---|---|---|
| ASITN cerebral vascular collaterality score > 2 | American Society of Interventional and Therapeutic Neuroradiology (ASITN) cerebral vascular collaterality score ranges from 0 (no collaterals visible to the ischemic site) to 4 (complete and rapid collateral blood flow to the vascular bed in the entire ischemic territory by retrograde perfusion). A score > 2 indicate at least collaterals with slow but complete angiographic blood flow of the ischemic bed by the late venous phase. | Before reperfusion of the occluded vessel |
| Measure | Description | Time Frame |
|---|---|---|
| ASITN cerebral vascular collaterality score | American Society of Interventional and Therapeutic Neuroradiology (ASITN) variation during the procedure | • At initial angiography in normocapnia and • Before reperfusion at randomized arterial CO2 tension level |
| Volume of cerebral infarction |
| Measure | Description | Time Frame |
|---|---|---|
| Pial Vascular Collaterality within the symptomatic ischemic territory at admission | Pial Vascular collaterality evaluated at admission with CT or MRI during patient selection for thrombectomy using the Pial Arterial Filling Score (from 0 indicated no collaterality to 5 indicating excellent collaterality) | At admission |
Inclusion Criteria:
• Large vessel occlusion anterior circulation stroke (terminal carotid artery and/or middle cerebral artery M1-M2 segment) eligible to mechanical thrombectomy under general anesthesia
Exclusion Criteria :
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lise Laclautre | Contact | +33 4 73 754963 | promo_interne_drci@chu-clermontferrand.fr |
| Name | Affiliation | Role |
|---|---|---|
| Russell Chabanne, MD MSc | University Hospital, Clermont-Ferrand | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU | Recruiting | Clermont-Ferrand | 63000 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31573636 | Background | Schonenberger S, Henden PL, Simonsen CZ, Uhlmann L, Klose C, Pfaff JAR, Yoo AJ, Sorensen LH, Ringleb PA, Wick W, Kieser M, Mohlenbruch MA, Rasmussen M, Rentzos A, Bosel J. Association of General Anesthesia vs Procedural Sedation With Functional Outcome Among Patients With Acute Ischemic Stroke Undergoing Thrombectomy: A Systematic Review and Meta-analysis. JAMA. 2019 Oct 1;322(13):1283-1293. doi: 10.1001/jama.2019.11455. | |
| 30009645 |
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| ID | Term |
|---|---|
| D000083242 | Ischemic Stroke |
| ID | Term |
|---|---|
| D020521 | Stroke |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| NORMOCAPNIA | Biological | Controlled normocapnia PaCO2 40mmHg under general anesthesia with mechanical ventilation |
|
Evaluated with Magnetic Resonance Imaging in milliliters |
| 24 hours after stroke |
| Progression of cerebral infarction | Evaluated with Magnetic Resonance Imaging or Computed Tomography in milliliters depending on type of radiological modality for patient selection | 24 hours after stroke |
| Neurological clinical outcome | Ordinal and dichotomized modified rankin scale (mRS) ranging from 0 (no disability) to 6 (death); good outcome will be defined as mRS 0-2. | 3 months |
| Arterial carbon dioxide tension |
Arterial carbon dioxide tension will be measured at 2 time points. |
| At groin puncture and at the end of procedure |
| Cerebral infarction extension | The Alberta Stroke Program Early Computed Tomography Score (ASPECTS) is an imaging measure of the extent of ischemic stroke. Scores range from 0 to 10, with higher scores indicating a smaller infarct core. | Before thrombectomy and at day 1 |
| Reperfusion assessed by mTICI | The modified Treatment In Cerebral Ischemia (mTICI) reperfusion scale ranging from 0 (no perfusion) to 3 (full perfusion with filling of all distal Branches). Good reperfusion will be defined as a score of 2B-3. | End of procedure |
| Procedural delay | Time frame from angiosuite admission to groin puncture to reperfusion if any | End of procedure |
| Number of procedural anesthetic and radiological complications | Procedural Safety outcomes | End of procedure |
| Number of Death and neurological complications | Safety outcomes | Day 7 |
| Background |
| Slupe AM, Kirsch JR. Effects of anesthesia on cerebral blood flow, metabolism, and neuroprotection. J Cereb Blood Flow Metab. 2018 Dec;38(12):2192-2208. doi: 10.1177/0271678X18789273. Epub 2018 Jul 16. |
| 29367334 | Background | Powers WJ, Rabinstein AA, Ackerson T, Adeoye OM, Bambakidis NC, Becker K, Biller J, Brown M, Demaerschalk BM, Hoh B, Jauch EC, Kidwell CS, Leslie-Mazwi TM, Ovbiagele B, Scott PA, Sheth KN, Southerland AM, Summers DV, Tirschwell DL; American Heart Association Stroke Council. 2018 Guidelines for the Early Management of Patients With Acute Ischemic Stroke: A Guideline for Healthcare Professionals From the American Heart Association/American Stroke Association. Stroke. 2018 Mar;49(3):e46-e110. doi: 10.1161/STR.0000000000000158. Epub 2018 Jan 24. |
| 22495584 | Background | Willie CK, Macleod DB, Shaw AD, Smith KJ, Tzeng YC, Eves ND, Ikeda K, Graham J, Lewis NC, Day TA, Ainslie PN. Regional brain blood flow in man during acute changes in arterial blood gases. J Physiol. 2012 Jul 15;590(14):3261-75. doi: 10.1113/jphysiol.2012.228551. Epub 2012 Apr 10. |
| 6658900 | Background | Olsen TS, Larsen B, Herning M, Skriver EB, Lassen NA. Blood flow and vascular reactivity in collaterally perfused brain tissue. Evidence of an ischemic penumbra in patients with acute stroke. Stroke. 1983 May-Jun;14(3):332-41. doi: 10.1161/01.str.14.3.332. |
| D009422 |
| Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |