CO2 Modulation in Endovascular Thrombectomy for Acute Ischemic Stroke

NCT05051397 | Recruiting Phase 2

• 2 other identifiers: COMET-AIS (AOI 2020 Chabanne)AOI...
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ischemic Stroke, Acute; Thrombectomy; Anesthesia, General; Cerebrovascular Circulation; Carbon Dioxide

Keywords

mechanical thrombectomy; large vessel occlusion stroke; carbon dioxide tension; cerebral blood flow; general anesthesia; cerebral collateral circulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• ASITN cerebral vascular collaterality score

  • At initial angiography in normocapnia and • Before reperfusion at randomized arterial CO2 tension level

• Volume of cerebral infarction

  24 hours after stroke

• Progression of cerebral infarction

  24 hours after stroke

• Neurological clinical outcome

  3 months

Other Outcomes (7)

• Pial Vascular Collaterality within the symptomatic ischemic territory at admission

  At admission

• Arterial carbon dioxide tension

  At groin puncture and at the end of procedure

• Cerebral infarction extension

  Before thrombectomy and at day 1

Study Arms (2)

HYPERCAPNIA

EXPERIMENTAL

Under general anesthesia with mechanical ventilation, PaCO2=50mmHg will be targeted

Biological: HYPERCAPNIA

NORMOCAPNIA

ACTIVE COMPARATOR

Under general anesthesia with mechanical ventilation, PaCO2=40mmHg will be targeted

Biological: NORMOCAPNIA

Interventions

HYPERCAPNIA BIOLOGICAL

Controlled moderate hypercapnia PaCO2 50mmHg under general anesthesia with mechanical ventilation

HYPERCAPNIA

NORMOCAPNIA BIOLOGICAL

Controlled normocapnia PaCO2 40mmHg under general anesthesia with mechanical ventilation

NORMOCAPNIA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Large vessel occlusion anterior circulation stroke (terminal carotid artery and/or middle cerebral artery M1-M2 segment) eligible to mechanical thrombectomy under general anesthesia

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Clermont-Ferrand: lead

Study Sites (1)

CHU

Clermont-Ferrand, 63000, France

RECRUITING

Related Publications (5)

• 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.

  PMID: 31573636 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.

  PMID: 30009645 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.

  PMID: 29367334 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.

  PMID: 22495584 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.

  PMID: 6658900 BACKGROUND

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Russell Chabanne, MD MSc

  University Hospital, Clermont-Ferrand

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lise Laclautre

CONTACT

+33 4 73 754963; promo_interne_drci@chu-clermontferrand.fr

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 9, 2021
• First Posted: September 21, 2021
• Study Start: July 20, 2022
• Primary Completion (Estimated): July 19, 2026
• Study Completion (Estimated): October 19, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)