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SETPOINT2 Will Help Define the Optimal Timing of Tracheostomy After Stroke By David B. Seder, MD, Silvia Schönenberger, MD, and Julian Bösel, MD Respiratory failure is thought to affect more than 10 percent of stroke patients, some of whom will require temporary tracheostomy to wean rapidly from mechanical ventilation. The timing of tracheostomy remains controversial. Proponents of early tracheostomy cite rapid weaning from sedation and analgesic infusions, shorter duration of mechanical ventilation, reliable secretion management, assured oxygenation and ventilation, and earlier participation in rehab activities. Skeptics believe early tracheostomy results in negligible benefits at a cost of excess tracheostomies. In 2011, the Heidelberg Neurocritical care group led by Julian Bösel published its experience with early tracheostomy for stroke in SETPOINT, a pilot study of 60 ventilated patients including all stroke subtypes. When the “SETscore,” a novel bedside scoring tool devised to predict the subsequent need for tracheostomy, was used to stratify patients, those randomized to an early tracheostomy (by day three) had decreased sedation administration and a higher rate of survival than those randomized to prolonged intubation/ delayed tracheostomy (between days seven and 14). In 2015, we initiated SETPOINT2, a phase III randomized controlled trial to compare the clinical effectiveness of early vs. delayed tracheostomy in stroke patients with respiratory failure likely to require tracheostomy. SETPOINT2 was designed with input from many stakeholders, including the neurocritical care research network, membership of NCS and DGNI, stroke patients and their family members, clergy, and advocacy groups, and by the clinical trials statistical group in Heidelberg. The trial is powered to detect an absolute 15 percent difference in the percentage of patients with mRS 0-4 vs. 5-6 at six months, with a target enrollment of 380 patients. By December of 2016, the trial was already 25 percent enrolled. In November of 2016, the Patient Centered Outcomes Research Institute (PCORI) informed us of their decision to fund SETPOINT2. The research contract of $2.56 million over three years will facilitate completion of the trial and fund additional research into the patient and family experience after severe stroke. We are honored to collaborate with PCORI, with our patients and families, and with the other stakeholders involved in this project. We are also delighted to build upon and foster the existing cooperation that exists among NCS, DGNI, IGNITE and the NCRN. Stay tuned as SETPOINT2 gets underway! You can expect to see a lot of data and hear a lot of discussion as we work to unravel the complicated knot of stroke, airway management, ventilation and recovery. Please chime in – we want to hear your thoughts! Dave, Silvia and Julian February 2017 David B. Seder, MD Silvia Schönenberger, MD Julian Bösel, MD 4


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