About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Active smoker
Chronic respiratory failure with ambulatory oxygen supplementation
Obesity with BMI>40Kg/ m2
Intubation before the procedure
Trial design
Parallel
Treatments tested in this trial
HYPERCAPNIA
Biological/VaccineControlled moderate hypercapnia PaCO2 50mmHg under general anesthesia with mechanical ventilation
NORMOCAPNIA
Biological/VaccineControlled normocapnia PaCO2 40mmHg under general anesthesia with mechanical ventilation
Treatment groups
Trial outcomes
Primary outcomes
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.
Secondary outcomes
ASITN cerebral vascular collaterality score
American Society of Interventional and Therapeutic Neuroradiology (ASITN) variation during the procedure
Volume of cerebral infarction
Evaluated with Magnetic Resonance Imaging in milliliters
Progression of cerebral infarction
Evaluated with Magnetic Resonance Imaging or Computed Tomography in milliliters depending on type of radiological modality for patient selection
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.
Other outcomes
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)
Arterial carbon dioxide tension
Arterial carbon dioxide tension will be measured at 2 time points.
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.
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.
Sponsors and contacts
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