Sedation vs. Intubation for Endovascular Stroke TreAtment

Not Applicable

Completed

• Conditions: Acute Ischemic Stroke
• Interventions: Procedure: Endovascular recanalisation

• Registration Number: NCT02126085
• Lead Sponsor: University Hospital Heidelberg

Brief Summary

Sedation vs Intubation for Endovascular Stroke TreAtment Trial (SIESTA) is a prospective, randomised controlled, monocentric, two-armed, comparative trial. Patients are randomized 1 : 1 to either non-intubated state or to intubated state for endovascular stroke treatment. Otherwise, no principal differences in intensive care treatment are intended, and standard operating procedures are applied to ensure uniform management decisions in fields such as ventilation, sedation, cardio-vascular and cerebral monitoring and management.

Detailed Description

Early recanalization is an important, if not the most important, factor concerning reconstitution of patients´ health in ischaemic stroke. This is the reason why patients with extended stroke are increasingly subjected to an endovascular stroke therapy (EST).

Matter of ongoing debate is how to sedate these patients during intervention. Some clinicians prefer an intubation due to a reduction of patients´movements and therefore potentially lowering complication rates (injury by catheter, aspiration e.g.).

On the other hand retrospective investigations hypothesize that general anaesthesia is associated with peri-interventional hypotension followed by poorer clinical outcome.

The best anaesthaesiologic management in endovascular stroke therapy to this point of time is not known. The investigators therefore designed this study comparing intubated state with general anaesthesia vs. non-intubated state with conscious sedation during EST, focusing on patients´ outcome.

Study Timeline

• Study Start: 2014-04
• Study First Submitted: 2014-04-23
• Study First Submitted QC: 2014-04-28
• Study First Posted: 2014-04-29
• Primary Completion: 2016-02
• Status Verified: 2016-05
• Study Completion: 2016-05
• Last Update Submitted: 2016-05-22
• Last Update Posted: 2016-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

• age ≥18 years
• acute stroke in anterior circulation
• occlusion of carotid artery and/ or middle cerebral artery
• planned mechanical recanalisation
• informed consent from patient or legal representative

Exclusion Criteria

• age < 18 years
• informed consent not obtainable
• coma
• agitation
• vomiting
• difficult airway management
• additional cerebral hemorrhage

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
No Intubation	Endovascular recanalisation	Conscious sedation and non-invasive ventilatory support + endovascular recanalisation
Intubation	Endovascular recanalisation	Intubation and invasive mechanical ventilation + endovascular recanalisation

Primary Outcome Measures

Name	Time	Method
National Institutes of Health Stroke Scale (NIHSS) after 24 hours	24 hours	Neurological improvement of NIHSS 24 hours after intervention

Secondary Outcome Measures

Name	Time	Method
Mortality-rate within the first 3 months after intervention.	First 3 months after intervention
Inpatient-mortality	Mortality-rate until timepoint of discharge, an expected average of 3 weeks.
Outcome after 3 month using the modified Rankin Scale (mRS)	3 month	Assessing the neurological outcome after 3 months with the mRS.

Trial Locations

Locations (1)

Department of Neurology, University Hospital Heidelberg; 🇩🇪 Heidelberg, Baden-Württemberg, Germany