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)

International Journal of Stroke : Official Journal of the International Stroke Society
Silvia SchönenbergerIGNITE-Study Group

Abstract

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. 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-s...Continue Reading

Associated Clinical Trials

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Citations

Aug 20, 2016·Journal of the Neurological Sciences·Vasileios-Arsenios LioutasSandeep Kumar
Jul 25, 2017·Stroke; a Journal of Cerebral Circulation·Julian Bösel
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Oct 13, 2021·Journal of Intensive Care Medicine·Christopher M KappChristoph T Hutchinson

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Methods Mentioned

BETA
sedation

Clinical Trials Mentioned

NCT02377167

Software Mentioned

SPSS
SETPOINT
ADDPLAN
SETPOINT2
SAS

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