title: Early tracheostomy in ventilated stroke patients: Study protocol of the international multicentre randomized trial SETPOINT2 (Stroke-related Early Tracheostomy vs. Prolonged Orotracheal Intubation in Neurocritical care Trial 2).
abstract: BACKGROUND
  Tracheostomy is a common procedure in long-term ventilated critical care patients and frequently necessary in those with severe stroke. The optimal timing for tracheostomy is still unknown, and it is controversial whether early tracheostomy impacts upon functional outcome.
  
  
  METHODS
  The Stroke-related Early Tracheostomy vs. Prolonged Orotracheal Intubation in Neurocritical care Trial 2 (SETPOINT2) is a multicentre, prospective, randomized, open-blinded endpoint (PROBE-design) trial. Patients with acute ischemic stroke, intracerebral hemorrhage or subarachnoid hemorrhage who are so severely affected that two weeks of ventilation are presumed necessary based on a prediction score are eligible. It is intended to enroll 190 patients per group (n = 380). Patients are randomized to either percutaneous tracheostomy within the first five days after intubation or to ongoing orotracheal intubation with consecutive weaning and extubation and, if the latter failed, to percutaneous tracheostomy from day 10 after intubation. The primary endpoint is functional outcome defined by the modified Rankin Scale (mRS, 0-4 (favorable) vs. 5 + 6 (unfavorable)) after six months; secondary endpoints are mortality and cause of mortality during intensive care unit-stay and within six months from admission, intensive care unit-length of stay, duration of sedation, duration of ventilation and weaning, timing and reasons for withdrawal of life support measures, relevant intracranial pressure rises before and after tracheostomy.
  
  
  CONCLUSIONS
  The necessity and optimal timing of tracheostomy in ventilated stroke patients need to be identified. SETPOINT2 should clarify whether benefits in functional outcome can be achieved by early tracheostomy in these patients.
authors.affiliation: Department of Neurology, University of Heidelberg, Heidelberg, Germany.
authors.forename: Silvia
authors.initials: S
authors.lastname: Schönenberger
authors.affiliation: Department of Neurology, University of Freiburg, Freiburg im Breisgau, Germany.
authors.forename: Wolf-Dirk
authors.initials: WD
authors.lastname: Niesen
authors.affiliation: Department of Neurology, University of Freiburg, Freiburg im Breisgau, Germany.
authors.forename: Hannah
authors.initials: H
authors.lastname: Fuhrer
authors.affiliation: Department of Public Health Sciences, Medical University of South Carolina, Charleston, South Carolina, USA.
authors.forename: Colleen
authors.initials: C
authors.lastname: Bauza
authors.affiliation: Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
authors.forename: Christina
authors.initials: C
authors.lastname: Klose
authors.affiliation: Institute of Medical Biometry and Informatics, University of Heidelberg, Heidelberg, Germany.
authors.forename: Meinhard
authors.initials: M
authors.lastname: Kieser
authors.affiliation: Division of Vascular Neurology and Neurocritical Care, Department of Neurology, Baylor College of Medicine, Houston, Texas, USA.
authors.forename: José I
authors.initials: JI
authors.lastname: Suarez
authors.affiliation: Department of Critical Care Services, Maine Medical Center, Portland, Maine, USA.
authors.forename: David B
authors.initials: DB
authors.lastname: Seder
authors.affiliation: Department of Neurology, University of Heidelberg, Heidelberg, Germany julian.boesel@med.uni-heidelberg.de.
authors.forename: Julian
authors.initials: J
authors.lastname: Bösel
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D005260:Female; D006801:Humans; D007391:International Cooperation; D008297:Male; D008875:Middle Aged; D011446:Prospective Studies; D012121:Respiration, Artificial; D020521:Stroke / Q000601:surgery* / Q000628:therapy; D013997:Time Factors; D014139:Tracheostomy; D016896:Treatment Outcome; D055815:Young Adult
keywords: Ischemic stroke; clinical trial; intracerebral hemorrhage; neurocritical care; tracheostomy; weaning