ABSTRACT
<p><b>BACKGROUND</b>Tracheostomy should be considered to replace endotracheal intubation in patients requiring prolonged mechanical ventilation (MV). However, the optimal timing for tracheostomy is still a topic of debate. The present study aimed to investigate whether early percutaneous dilational tracheostomy (PDT) can reduce duration of MV, and to further verify whether early PDT can reduce sedative use, shorten intensive care unit (ICU) stay, decrease the incidence of ventilator associated pneumonia (VAP), and increase successful weaning and ICU discharge rate.</p><p><b>METHODS</b>A prospective, randomized controlled trial was carried out in a surgical ICU from July 2008 to June 2011 in adult patients anticipated requiring prolonged MV via endotracheal intubation. Patients meeting the inclusion criteria were randomly assigned to the early PDT group or the late PDT group on day 3 of MV. The patients in the early PDT group were tracheostomized with PDT on day 3 of MV. The patients in the late PDT group were tracheostomized with PDT on day 15 of MV if they still needed MV. The primary endpoint was ventilator-free days at day 28 after randomization. The secondary endpoints were sedation-free days, ICU-free days, successful weaning and ICU discharge rate, and incidence of VAP at day 28 after randomization. The cumulative 60-day incidence of death after randomization was also analyzed.</p><p><b>RESULTS</b>Total 119 patients were randomized to either the early PDT group (n = 58) or the late PDT group (n = 61). The ventilator-free days was significantly increased in the early PDT group than in the late PDT group ((9.57 ± 5.64) vs. (7.38 ± 6.17) days, P < 0.05). The sedation-free days and ICU-free days were also significantly increased in the early PDT group than in the late PDT group (20.84 ± 2.35 vs. 17.05 ± 2.30 days, P < 0.05; and 8.0 (interquartile range (IQR): 5.0 - 12.0) vs. 3.0 (IQR: 0 - 12.0) days, P < 0.001 respectively). The successful weaning and ICU discharge rate was significantly higher in early PDT group than in late PDT group (74.1% vs. 55.7%, P < 0.05; and 67.2% vs. 47.5%, P < 0.05 respectively). VAP was observed in 17 patients (29.3%) in early PDT group and in 30 patients (49.2%) in late PDT group (P < 0.05). There was no significant difference between the two groups in the cumulative 60-day incidence of death after randomization (P = 0.949).</p><p><b>CONCLUSIONS</b>The early PDT resulted in more ventilator-free, sedation-free, and ICU-free days, higher successful weaning and ICU discharge rate, and lower incidence of VAP, but did not change the cumulative 60-day incidence of death in the patients' anticipated requiring prolonged mechanical ventilation.</p>