Sedation vs. Intubation for Endovascular Stroke TreAtment

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sedation vs. Intubation for Endovascular Stroke TreAtment

Conditions
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Acute Ischemic Stroke

Intervention / Treatment
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* Procedure: Endovascular recanalisation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intubation<br>Intubation and invasive mechanical ventilation + endovascular recanalisation | Procedure: Endovascular recanalisation<br>* Endovascular recanalisation by mechanical thrombectomy with e.g. stent retriever device, possibly following intravenous thrombolysis within a bridging concept<br>|
| Experimental: No Intubation<br>Conscious sedation and non-invasive ventilatory support + endovascular recanalisation | Procedure: Endovascular recanalisation<br>* Endovascular recanalisation by mechanical thrombectomy with e.g. stent retriever device, possibly following intravenous thrombolysis within a bridging concept<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| National Institutes of Health Stroke Scale (NIHSS) after 24 hours | Neurological improvement of NIHSS 24 hours after intervention | 24 hours | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, recanalisation, sedation