SETPOINT 2 Trial – Early Vs Late Tracheostomy in Stroke patients

Blog Written by – Dr Jose Chacko

Effect of Early vs Standard Approach to Tracheostomy on Functional Outcome at 6 Months Among Patients With Severe Stroke Receiving Mechanical Ventilation The SETPOINT2 Randomized Clinical Trial

Background

In the SETPOINT pilot study, 60 patients with stroke on mechanical ventilation were randomized to tracheostomy within 3 days of intubation or between days 7 and 14 if they remained intubated. The ICU length of stay, the primary endpoint, was similar. However, sedation use, duration of mechanical ventilation, and mortality were lower with an early tracheostomy. The present multicenter randomized trial, SETPOINT2 investigated the potential benefits of early vs standard tracheostomy in patients with severe stroke receiving mechanical ventilation.

Population/setting

The study was conducted over a 5-y period in 26 neurocritical care units in Germany and the US. The study population included patients on mechanical ventilation after acute ischemic stroke, and intracerebral or subarachnoid hemorrhage if the stroke-related early tracheostomy score (SETscore) was >10. The patient would require prolonged ventilation and tracheostomy, according to clinician’s judgment.

Excluded

• Premorbid modified Rankin Score >1
• Ventilated for >4 days
• Clinical contraindication for early tracheostomy or requirement for surgical tracheostomy
• Pregnancy
• Life expectancy less that 3 weeks

Early group

Tracheostomy within 5 days of intubation

Late Group

Tracheostomy from day 10, if extubation not possible by then

Common to both groups

Most patients underwent bedside percutaneous dilatational tracheostomy. Transition to open tracheostomy if clinically indicated. Ventilation, weaning, analgesia, sedation, and neurological monitoring were based on local practice, but largely based on AHA and ASA guidelines.

Sample size

The sample size was calculated using the modified Rankin Score, dichotomized as 0–4 (success) and 5–6 (failure). Assuming a success rate of 45% in the early compared to 30% in the late group, a sample size of 380 was chosen for a 2-sided type I error rate of 0.05 and a power of 80%.

Baseline characteristics

• The type of stroke (ischemic stroke, SAH, or ICH) was similar between groups. Disease-specific severity measures were also similar.
• 177/186 (95.2%) patients in the early tracheostomy group underwent tracheostomy at median of 4 days after intubation. Three patients were successfully extubated; six patients died before the procedure or deteriorated clinically precluding a tracheostomy
• 130/194 (67%) in the late tracheostomy group underwent tracheostomy at a median of 11 days after intubation. Of the remaining 64 patients, 43 were extubated, while 21 died before the procedure.
• 158/177 (89.3%) underwent PDT in the early group vs 108/130 (83.1%) in the late group.
• 366/380 patients were included in the final analysis; 13 were lost for follow-up while one patient withdrew consent.

Adverse events related to percutaneous tracheostomy included venous bleeding (2.6%) and aspiration pneumonia within 48 hours of tracheostomy (2.6%).

Subgroup analysis

No significant differences in functional outcomes in pre-defined subgroups of age, gender, German vs US treatment center, high-volume vs low-volume center, type of stroke subtype, or the presenting GCS.

Comments

• Only 67% in the late group underwent tracheostomy. This is similar to the Trackman trial in which a significant number of patients randomized to the late group did not undergo tracheostomy.
• The sample size was based on a large outcome difference; hence, a type II error is possible (small sample size)
• The primary outcome was based on a modified Rankin Score of 0–4; it is questionable whether a score of 4 can be considered to be a good outcome (unable to walk or attend to bodily functions without assistance)
• Tracheostomy outside the timelines employed in the study could lead to different outcomes.
• Fourteen patients were not included in the final analysis
• Blinding was not feasible; possible bias may be particularly relevant among patients who underwent limitation of care based on clinical judgment
• Patients had three different types of stroke; the outcome may be different in specific stroke types, e.g., ischemic stroke
• No standard weaning protocol; may have confounded the duration of ventilator support.

Our recommendation – 

Following the trajectory of the patient’s clinical recovery is the best way to decide the timing of tracheostomy.

Often these patients would avoid tracheostomy if they waited for the first couple of weeks.

Also, the prognosis of the underlying disease and the patient’s wishes should be considered before committing to tracheostomy.