Sedation vs. Intubation for Endovascular Stroke TreAtment

NCT02126085 | Completed

• 1 other identifier: SIESTA
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute Ischemic Stroke

Keywords

ischemic stroke; recanalisation; sedation

Outcome Measures

Primary Outcomes (1)

• National Institutes of Health Stroke Scale (NIHSS) after 24 hours

  Neurological improvement of NIHSS 24 hours after intervention

  24 hours

Secondary Outcomes (3)

• Outcome after 3 month using the modified Rankin Scale (mRS)

  3 month

• 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 Outcomes (3)

• Duration of hospital stay

  Participants will be followed until timepoint of discharge, an expected average of 3 weeks.

• 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

Study Arms (2)

Intubation

ACTIVE COMPARATOR

Intubation and invasive mechanical ventilation + endovascular recanalisation

Procedure: Endovascular recanalisation

No Intubation

EXPERIMENTAL

Conscious sedation and non-invasive ventilatory support + endovascular recanalisation

Procedure: Endovascular recanalisation

Interventions

Endovascular recanalisation PROCEDURE

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

Intubation; No Intubation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• age \< 18 years
• informed consent not obtainable
• coma
• agitation
• vomiting
• difficult airway management
• additional cerebral hemorrhage

Sponsors & Collaborators

• University Hospital Heidelberg: lead

Study Sites (1)

Department of Neurology, University Hospital Heidelberg

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Related Publications (9)

• Lees KR, Bluhmki E, von Kummer R, Brott TG, Toni D, Grotta JC, Albers GW, Kaste M, Marler JR, Hamilton SA, Tilley BC, Davis SM, Donnan GA, Hacke W; ECASS, ATLANTIS, NINDS and EPITHET rt-PA Study Group; Allen K, Mau J, Meier D, del Zoppo G, De Silva DA, Butcher KS, Parsons MW, Barber PA, Levi C, Bladin C, Byrnes G. Time to treatment with intravenous alteplase and outcome in stroke: an updated pooled analysis of ECASS, ATLANTIS, NINDS, and EPITHET trials. Lancet. 2010 May 15;375(9727):1695-703. doi: 10.1016/S0140-6736(10)60491-6.

  PMID: 20472172 BACKGROUND

• Rha JH, Saver JL. The impact of recanalization on ischemic stroke outcome: a meta-analysis. Stroke. 2007 Mar;38(3):967-73. doi: 10.1161/01.STR.0000258112.14918.24. Epub 2007 Feb 1.

  PMID: 17272772 BACKGROUND

• Nogueira RG, Liebeskind DS, Sung G, Duckwiler G, Smith WS; MERCI; Multi MERCI Writing Committee. Predictors of good clinical outcomes, mortality, and successful revascularization in patients with acute ischemic stroke undergoing thrombectomy: pooled analysis of the Mechanical Embolus Removal in Cerebral Ischemia (MERCI) and Multi MERCI Trials. Stroke. 2009 Dec;40(12):3777-83. doi: 10.1161/STROKEAHA.109.561431. Epub 2009 Oct 29.

  PMID: 19875740 BACKGROUND

• Bosel J, Hacke W, Bendszus M, Rohde S. Treatment of acute ischemic stroke with clot retrieval devices. Curr Treat Options Cardiovasc Med. 2012 Jun;14(3):260-72. doi: 10.1007/s11936-012-0172-y.

  PMID: 22392611 BACKGROUND

• McDonagh DL, Olson DM, Kalia JS, Gupta R, Abou-Chebl A, Zaidat OO. Anesthesia and Sedation Practices Among Neurointerventionalists during Acute Ischemic Stroke Endovascular Therapy. Front Neurol. 2010 Nov 11;1:118. doi: 10.3389/fneur.2010.00118. eCollection 2010.

  PMID: 21188256 BACKGROUND

• Davis MJ, Menon BK, Baghirzada LB, Campos-Herrera CR, Goyal M, Hill MD, Archer DP; Calgary Stroke Program. Anesthetic management and outcome in patients during endovascular therapy for acute stroke. Anesthesiology. 2012 Feb;116(2):396-405. doi: 10.1097/ALN.0b013e318242a5d2.

  PMID: 22222475 BACKGROUND

• Tosello R, Riera R, Tosello G, Clezar CN, Amorim JE, Vasconcelos V, Joao BB, Flumignan RL. Type of anaesthesia for acute ischaemic stroke endovascular treatment. Cochrane Database Syst Rev. 2022 Jul 20;7(7):CD013690. doi: 10.1002/14651858.CD013690.pub2.

  PMID: 35857365 DERIVED

• Schonenberger S, Uhlmann L, Ungerer M, Pfaff J, Nagel S, Klose C, Bendszus M, Wick W, Ringleb PA, Kieser M, Mohlenbruch MA, Bosel J. Association of Blood Pressure With Short- and Long-Term Functional Outcome After Stroke Thrombectomy: Post Hoc Analysis of the SIESTA Trial. Stroke. 2018 Jun;49(6):1451-1456. doi: 10.1161/STROKEAHA.117.019709. Epub 2018 May 2.

  PMID: 29720440 DERIVED

• Schonenberger S, Uhlmann L, Hacke W, Schieber S, Mundiyanapurath S, Purrucker JC, Nagel S, Klose C, Pfaff J, Bendszus M, Ringleb PA, Kieser M, Mohlenbruch MA, Bosel J. Effect of Conscious Sedation vs General Anesthesia on Early Neurological Improvement Among Patients With Ischemic Stroke Undergoing Endovascular Thrombectomy: A Randomized Clinical Trial. JAMA. 2016 Nov 15;316(19):1986-1996. doi: 10.1001/jama.2016.16623.

  PMID: 27785516 DERIVED

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Julian Bösel, PD

  Department of Neurology, University Hospital Heidelberg

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Leading sub-investigator, Principal Investigator: PD Dr. Julian Bösel, MD

Study Record Dates

• First Submitted: April 23, 2014
• First Posted: April 29, 2014
• Study Start: April 1, 2014
• Primary Completion: February 1, 2016
• Study Completion: May 1, 2016
• Last Updated: May 24, 2016

Record last verified: 2016-05

Locations

DE (1)