Acute Ischemic Stroke
Conditions
Keywords
ischemic stroke, recanalisation, sedation
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.
Interventions
PROCEDUREEndovascular recanalisation
Endovascular recanalisation by mechanical thrombectomy with e.g. stent retriever device, possibly following intravenous thrombolysis within a bridging concept
Sponsors
University Hospital Heidelberg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| National Institutes of Health Stroke Scale (NIHSS) after 24 hours | 24 hours | Neurological improvement of NIHSS 24 hours after intervention |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Outcome after 3 month using the modified Rankin Scale (mRS) | 3 month | Assessing the neurological outcome after 3 months with the mRS. |
| 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 | — |
Other
| Measure | Time frame | Description |
|---|---|---|
| Periinterventional complications | Evaluation of Adverse Events as a Measure of Safety and Tolerability until timepoint of discharge, an expected average of 3 weeks. | — |
| Achieved recanalisation grade | Duration of intervention with an expected average of 2 hours | Recanalisation status is classified according to the Thrombolysis in Cerebral Infarction classification (TICI). |
| Duration of hospital stay | Participants will be followed until timepoint of discharge, an expected average of 3 weeks. | — |
Countries
Germany
Outcome results
None listed