Sedation vs. Intubation for Endovascular Stroke TreAtment (SIESTA)

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Dr. Silvia Schönenberger, MD, University Hospital Heidelberg

ClinicalTrials.gov Identifier:

NCT02126085

First received: April 23, 2014

Last updated: May 22, 2016

Last verified: May 2016

History of Changes

Tracking Information

First Received Date ^ICMJE

April 23, 2014

Last Updated Date

May 22, 2016

Start Date ^ICMJE

April 2014

Primary Completion Date

February 2016 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

National Institutes of Health Stroke Scale (NIHSS) after 24 hours [ Time Frame: 24 hours ]

Neurological improvement of NIHSS 24 hours after intervention

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT02126085 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

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).

Original Other Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

Sedation vs. Intubation for Endovascular Stroke TreAtment

Official Title ^ICMJE

Sedation vs. Intubation for Endovascular Stroke TreAtment

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.

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Acute Ischemic Stroke

Intervention ^ICMJE

Procedure: Endovascular recanalisation

Endovascular recanalisation by mechanical thrombectomy with e.g. stent retriever device, possibly following intravenous thrombolysis within a "bridging concept"

Study Arms

Active Comparator: Intubation
Intubation and invasive mechanical ventilation + endovascular recanalisation

Intervention: Procedure: Endovascular recanalisation
Experimental: No Intubation
Conscious sedation and non-invasive ventilatory support + endovascular recanalisation

Intervention: Procedure: Endovascular recanalisation

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

150

Completion Date

May 2016

Primary Completion Date

February 2016 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Germany

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02126085

Other Study ID Numbers ^ICMJE

SIESTA

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Not Provided

Responsible Party

Dr. Silvia Schönenberger, MD, University Hospital Heidelberg

Study Sponsor ^ICMJE

University Hospital Heidelberg

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Julian Bösel, PD

Department of Neurology, University Hospital Heidelberg

PRS Account

University Hospital Heidelberg

Verification Date

May 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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