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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05051397
Other study ID # COMET-AIS (AOI 2020 Chabanne)
Secondary ID AOI...
Status Recruiting
Phase Phase 2
First received
Last updated
Start date July 20, 2022
Est. completion date October 19, 2024

Study information

Verified date December 2022
Source University Hospital, Clermont-Ferrand
Contact Lise Laclautre
Phone +33 4 73 754963
Email promo_interne_drci@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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: - Rapid sequence induction for orotracheal intubation with PROPOFOL 2mg/Kg and SUXAMETHONIUM 1mg/Kg - SUFENTANIL 0,1 µg/Kg and CISATRACURIUM 0,1mg/Kg - Maintenance with intravenous continuous infusion of PROPOFOL targeting a BISpectral index 40 to 60 - Systolic blood pressure will have to be maintained +/- 10% of preoperative baseline value with limits between 120 and 185mmHg (with NOREPINEPHRINE as needed) - Mechanical ventilation will use Tidal Volume of 7mL/Kg of ideal body weight, respiratory rate of 15/minute, End expiratory pressure of 5cmH2O. FiO2 will target SpO2 95-98%. Initial End Tidal CO2 (EtCO2) target will be 35mmHg. - A first arterial blood gas analysis at groin puncture will evaluate CO2 alveolar-arterial gradient in order to obtain the expected PaCO2 in each group with respiratory rate modulation on the ventilator. - ASITN baseline collaterality score will be evaluated at initial angiography with normocapnia in each group. A second evaluation of ASITN will be done just before deployment of intraarterial revascularisation device in hypercapnia or normocapnia depending on randomisation group. - Targeted PaCO2 will have to be maintained using EtCO2 surrogate until the end of procedure. - A second arterial blood gas analysis at the end of procedure will evaluate final PaCO2.


Recruitment information / eligibility

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

Study Design


Intervention

Biological:
HYPERCAPNIA
Controlled moderate hypercapnia PaCO2 50mmHg under general anesthesia with mechanical ventilation
NORMOCAPNIA
Controlled normocapnia PaCO2 40mmHg under general anesthesia with mechanical ventilation

Locations

Country Name City State
France CHU Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

References & Publications (5)

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. — View Citation

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. Erratum In: Stroke. 2018 Mar;49(3):e138. Stroke. 2018 Apr 18;: — View Citation

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. Erratum In: JAMA. 2019 Dec 24;322(24):2445. — View Citation

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. — View Citation

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. — View Citation

Outcome

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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