Sedation vs. Intubation for Endovascular Stroke TreAtment (SIESTA)

University Hospital Heidelberg

Status: Completed

Conditions: Acute Ischemic Stroke

Treatments: Procedure: Endovascular recanalisation

Study type: Interventional

Funder types: Other

Identifiers

NCT02126085

SIESTA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 150 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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150 participants in 2 patient groups

Intubation

Active Comparator group

Description:

Intubation and invasive mechanical ventilation + endovascular recanalisation

Treatment:

Procedure: Endovascular recanalisation

No Intubation

Experimental group

Description:

Conscious sedation and non-invasive ventilatory support + endovascular recanalisation

Treatment:

Procedure: Endovascular recanalisation