Anesthesia, General Clinical Trial
— COMET-AISOfficial title:
Evaluation of the Effect of Moderate and Controlled Hypercapnia on Ischemic Penumbra Vascular Collaterality During General Anesthesia for Anterior Circulation Acute Ischemic Stroke Mechanical Thrombectomy
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.
Status | Recruiting |
Enrollment | 50 |
Est. completion date | October 19, 2024 |
Est. primary completion date | June 19, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 : - Active smoker - Chronic respiratory failure with ambulatory oxygen supplementation - Obesity with BMI>40Kg/ m2 - Intubation before the procedure - Heart failure with intolerance to decubitus - Severe renal failure - Suspected elevated intracranial pressure - Pregnant or breastfeeding women |
Country | Name | City | State |
---|---|---|---|
France | CHU | Clermont-Ferrand |
Lead Sponsor | Collaborator |
---|---|
University Hospital, Clermont-Ferrand |
France,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Other | Arterial carbon dioxide tension | Arterial carbon dioxide tension will be measured at 2 time points. | At groin puncture and at the end of procedure | |
Other | 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 | |
Other | 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 | |
Other | Procedural delay | Time frame from angiosuite admission to groin puncture to reperfusion if any | End of procedure | |
Other | Number of procedural anesthetic and radiological complications | Procedural Safety outcomes | End of procedure | |
Other | Number of Death and neurological complications | Safety outcomes | Day 7 | |
Primary | 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 | |
Secondary | 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 | |
Secondary | Volume of cerebral infarction | Evaluated with Magnetic Resonance Imaging in milliliters | 24 hours after stroke | |
Secondary | 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 | |
Secondary | 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 |
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