Anaesthesiological Routine Care for Thrombectomy in Cerebral Ischaemia

Cerebral Ischemia Clinical Trial

Official title:

Anaesthesiological Routine Care for Thrombectomy in Cerebral Ischaemia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04522856
• Other study ID #: ARCTIC-I
• Status: Recruiting
• Start date: August 1, 2021
• Est. completion date: August 30, 2024

Study information

• Verified date: April 2024
• Source: European Society of Anaesthesiology
• Contact: Andreas Ranft, Dr.
• Phone: 004989 4140 9632
• Email: andreas.ranft[@]tum.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

see brief summary

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2500
• Est. completion date: August 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Ischemia
• Cerebral Infarction
• Cerebral Ischemia
• Ischemia

Locations

Country	Name	City	State
Germany	TU München	München

Sponsors (1)

Lead Sponsor	Collaborator
European Society of Anaesthesiology

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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