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Sedation vs. Intubation for Endovascular Stroke TreAtment (SIESTA)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02126085
First Posted: April 29, 2014
Last Update Posted: May 24, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Dr. Silvia Schönenberger, MD, University Hospital Heidelberg
  Purpose
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.

Condition Intervention
Acute Ischemic Stroke Procedure: Endovascular recanalisation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sedation vs. Intubation for Endovascular Stroke TreAtment

Further study details as provided by Dr. Silvia Schönenberger, MD, University Hospital Heidelberg:

Primary Outcome Measures:
  • National Institutes of Health Stroke Scale (NIHSS) after 24 hours [ Time Frame: 24 hours ]
    Neurological improvement of NIHSS 24 hours after intervention


Secondary Outcome Measures:
  • Outcome after 3 month using the modified Rankin Scale (mRS) [ Time Frame: 3 month ]
    Assessing the neurological outcome after 3 months with the mRS.

  • Inpatient-mortality [ Time Frame: Mortality-rate until timepoint of discharge, an expected average of 3 weeks. ]
  • Mortality-rate within the first 3 months after intervention. [ Time Frame: First 3 months after intervention ]

Other Outcome Measures:
  • Duration of hospital stay [ Time Frame: Participants will be followed until timepoint of discharge, an expected average of 3 weeks. ]
  • Periinterventional complications [ Time Frame: Evaluation of Adverse Events as a Measure of Safety and Tolerability until timepoint of discharge, an expected average of 3 weeks. ]
  • Achieved recanalisation grade [ Time Frame: Duration of intervention with an expected average of 2 hours ]
    Recanalisation status is classified according to the Thrombolysis in Cerebral Infarction classification (TICI).


Enrollment: 150
Study Start Date: April 2014
Study Completion Date: May 2016
Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Intubation
Intubation and invasive mechanical ventilation + endovascular recanalisation
Procedure: Endovascular recanalisation
Endovascular recanalisation by mechanical thrombectomy with e.g. stent retriever device, possibly following intravenous thrombolysis within a "bridging concept"
Experimental: No Intubation
Conscious sedation and non-invasive ventilatory support + endovascular recanalisation
Procedure: Endovascular recanalisation
Endovascular recanalisation by mechanical thrombectomy with e.g. stent retriever device, possibly following intravenous thrombolysis within a "bridging concept"

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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02126085


Locations
Germany
Department of Neurology, University Hospital Heidelberg
Heidelberg, Baden-Württemberg, Germany, 69120
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
Principal Investigator: Julian Bösel, PD Department of Neurology, University Hospital Heidelberg
  More Information

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Silvia Schönenberger, MD, Leading sub-investigator, Principal Investigator: PD Dr. Julian Bösel, MD, University Hospital Heidelberg
ClinicalTrials.gov Identifier: NCT02126085     History of Changes
Other Study ID Numbers: SIESTA
First Submitted: April 23, 2014
First Posted: April 29, 2014
Last Update Posted: May 24, 2016
Last Verified: May 2016

Keywords provided by Dr. Silvia Schönenberger, MD, University Hospital Heidelberg:
ischemic stroke
recanalisation
sedation

Additional relevant MeSH terms:
Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases