Anaesthesiological Routine Care for Thrombectomy in Cerebral Ischaemia

Endovascular thrombectomy is the standard of care for acute ischaemic stroke due to large-vessel occlusion. Current guidelines for periprocedural anaesthesiological care give gross recommendations on management of stroke patients during recanalization, but lack detailed information.

To determine how anaesthesiologists support endovascular thrombectomy with regard to anaesthetic technique, choice of substances, haemodynamic management, and ventilation. With a multivariate analysis, the investigators will look for the factors of anesthetic management that are independently correlated with a good or bad outcome.

Study Overview

• Status: Recruiting
• Conditions: Cerebral Ischemia

Detailed Description

see brief summary

• Study Type: Observational
• Enrollment (Estimated): 2500

Contacts and Locations

• Study Contact: Name: Andreas Ranft, Dr.; Phone Number: 004989 4140 9632; Email: andreas.ranft@tum.de

Study Locations

• Germany
  • München, Germany
    • Recruiting
    • TU München
    • Contact: ESAIC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The target population consists of patients undergoing emergency endovascular thrombectomy for treatment of AIS-LVO. The planned minimum sample size is 5,000 patients.

Description

Inclusion Criteria:

• Endovascular stroke treatment involving anaesthesia care

Exclusion Criteria:

• In-hospital onset of stroke
• Inclusion in an interventional study concerning the anaesthesia protocol
• Age under 18 years

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Endovascular thrombectomy; there is only one group of the subjects that had stroke and went under thrombectomy procedure and to see how anaesthesiologists support endovascular thrombectomy with regard to anaesthetic technique,choice of substances, haemodynamic management, and ventilation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neurological outcome 90 days after the stroke	Neurological outcome is measured using the modified Rankin Scale [0-6], with higher values indicating worse outcome. As a Primary Outcome Measure, the scale will be dichotomized into good (modified Rankin Scale ≤ 2) versus poor (modified Rankin Scale > 2) outcome.	90 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Mortality rate 90 days after the stroke. Mortality rate is the percentage of patients that have died within 90 days following their stroke.	90 days
Grade of recanalization	Recanalization is classified according to the modified Thrombolysis in Cerebral Infarction classification (mTICI) [0 - 3], with higher values indicating better reperfusion.	sixty minutes
Duration	Duration [minutes] from patient's arrival in angiography suite to arterial puncture for endovascular thrombectomy. Duration [minutes] from patient's arrival in angiography suite to arterial puncture for endovascular thrombectomy. Duration [minutes] from arterial puncture to end of endovascular thrombectomy.	30 Minutes
Proportion of patients breathing spontaneously	Proportion of patients breathing spontaneously after thrombectomy [Time Frame: On transfer from angiography suite after thrombectomy, which typically takes 1 hour]. This is defined as percentage of patients that breathe spontaneously without laryngeal mask, laryngeal tube, or endotracheal tube after thrombectomy.	sixty minutes

Collaborators and Investigators

• Sponsor: European Society of Anaesthesiology
• Investigators: Study Chair: Andreas Ranft, Dr., Senior Physician-München, Germany

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2021
• Primary Completion (Estimated): April 30, 2024
• Study Completion (Estimated): August 30, 2024

Study Registration Dates

• First Submitted: June 15, 2020
• First Submitted That Met QC Criteria: August 18, 2020
• First Posted (Actual): August 21, 2020

Study Record Updates

• Last Update Posted (Actual): April 17, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: acute ischaemic stroke; Endovascular thrombectomy; large-vessel occlusion
• Additional Relevant MeSH Terms: Pathologic Processes; Necrosis; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Infarction; Stroke; Brain Infarction; Brain Ischemia; Ischemia; Cerebral Infarction
• Other Study ID Numbers: ARCTIC-I

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No