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)
Restricted accessResearch articleFirst published online April, 2016
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)
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.
Method
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.
Conclusion
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.
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