Benefits of early tracheostomy in ventilated stroke patients? Current evidence and study protocol of the randomized pilot trial SETPOINT (Stroke-related Early Tracheostomy vs. Prolonged Orotracheal Intubation in Neurocritical care Trial).

RATIONALE: Ventilated intensive care patients with ischemic or hemorrhagic strokes have a poor prognosis. Early tracheostomy has led to advantages in selected groups of non-cerebrovascular intensive care patients, including shorter ventilation time, shorter intensive care unit length of stay, and reduced complications. It is completely unclear whether ventilated stroke patients might benefit from early tracheostomy, too. AIM: Stroke-related Early Tracheostomy vs. Prolonged Orotracheal Intubation in Neurocritical care Trial (SETPOINT) is a pilot trial aiming to investigate the safety, feasibility, and potential benefits of early tracheostomy vs. prolonged intubation (and possibly late tracheostomy) in patients with severe ischemic stroke, intracerebral hemorrhage, or subarachnoid hemorrhage. The primary objective is to compare early tracheostomy and prolonged intubation with respect to the intensive care unit - length of stay and the time until the start of rehabilitation in these patients.
DESIGN: SETPOINT is a prospective, randomized, controlled, outcome observer-blinded, monocenter trial. Patients with severe ischemic stroke, intracerebral or subarachnoid hemorrhage requiring intubation and ventilation are eligible. After passing predefined criteria, enrolled patients are randomized to either percutaneous tracheostomy within the first three-days from intubation or to weaning/extubation attempts or percutaneous tracheostomy between days 7 and 14 from intubation (n = 30 per group). STUDY OUTCOMES: The primary end-point is the intensive care unit length of stay. Secondary end-points are functional outcome and mortality at discharge and after six-months, duration to transferability, duration of ventilation, duration and quality of weaning from respirator, need of analgesia and sedation, procedure-related complications, frequency of pneumonia and sepsis, and costs of treatment. DISCUSSION: To clarify the potential benefit of early tracheostomy in critical care ventilated stroke patients, a randomized multicenter trial in a larger patient population is clearly needed. If this monocentric pilot gives promising safety, feasibility, and benefit results, such a multicenter trial will be planned. The results will have a relevant direct impact on the critical care of stroke.

RCT Entities:   Population Interventions Outcomes