Sedation vs. Intubation for Endovascular Stroke TreAtment (SIESTA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital Heidelberg
Sponsor:
Information provided by (Responsible Party):
Dr. Silvia Schönenberger, MD, University Hospital Heidelberg
ClinicalTrials.gov Identifier:
NCT02126085
First received: April 23, 2014
Last updated: April 29, 2014
Last verified: April 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Sedation vs. Intubation for Endovascular Stroke TreAtment

Resource links provided by NLM:


Further study details as provided by University Hospital Heidelberg:

Primary Outcome Measures:
  • National Institutes of Health Stroke Scale (NIHSS) after 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
  • Mortality-rate within the first 3 months after intervention. [ Time Frame: First 3 months after intervention ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Duration of hospital stay [ Time Frame: Participants will be followed until timepoint of discharge, an expected average of 3 weeks. ] [ Designated as safety issue: No ]
  • 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. ] [ Designated as safety issue: No ]
  • Achieved recanalisation grade [ Time Frame: Duration of intervention with an expected average of 2 hours ] [ Designated as safety issue: No ]
    Recanalisation status is classified according to the Thrombolysis in Cerebral Infarction classification (TICI).


Estimated Enrollment: 100
Study Start Date: April 2014
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: March 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02126085

Contacts
Contact: Silvia Schönenberger, Dr. 0049-6221-5637549 silvia.schoenenberger@med.uni-heidelberg.de

Locations
Germany
Department of Neurology, University Hospital Heidelberg Recruiting
Heidelberg, Baden-Württemberg, Germany, 69120
Contact: Silvia Schönenberger, Dr.    0049-6221-5637549    silvia.schoenenberger@med.uni-heidelberg.de   
Sub-Investigator: Silvia Schönenberger, Dr.         
Sponsors and Collaborators
University Hospital Heidelberg
Investigators
Principal Investigator: Julian Bösel, PD Department of Neurology, University Hospital Heidelberg
  More Information

Publications:

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
Study First Received: April 23, 2014
Last Updated: April 29, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital Heidelberg:
ischemic stroke
recanalisation
sedation

Additional relevant MeSH terms:
Ischemia
Stroke
Cerebral Infarction
Pathologic Processes
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on July 20, 2014