Sedation vs. Intubation for Endovascular Stroke TreAtment "SIESTA"

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Endovascular recanalisation Procedure
    Intervention Desc: Endovascular recanalisation by mechanical thrombectomy with e.g. stent retriever device, possibly following intravenous thrombolysis within a "bridging concept"
    ARM 1: Kind: Experimental
    Label: Intubation
    Description: Intubation and invasive mechanical ventilation + endovascular recanalisation
    ARM 2: Kind: Experimental
    Label: No Intubation
    Description: Conscious sedation and non-invasive ventilatory support + endovascular recanalisation

Trial Design

  • Allocation: Randomized
  • Masking: Open Label
  • Purpose: Treatment
  • Endpoint: Efficacy Study
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary National Institutes of Health Stroke Scale (NIHSS) after 24 hours 24 hours No
Secondary Outcome after 3 month using the modified Rankin Scale (mRS) 3 month No
Secondary Inhouse-mortality Mortality-rate until timepoint of discharge, an expected average of 3 weeks. No
Secondary Mortality-rate within the first 3 months after intervention. First 3 months after intervention No
Secondary Inpatient-mortality Mortality-rate until timepoint of discharge, an expected average of 3 weeks. No

Sponsors