Early tracheostomy (ET) has been claimed to reduce ventilator support or intensive care unit or hospital length of stay in intensive care unit patients. This study was performed to assess the potential benefits of ET in burn patients. From October 1996 to July 2001, we evaluated all intubated and acutely burned adults using a formula to predict the probability of prolonged ventilator dependence. We randomized each patient with a probability of prolonged ventilator dependence more than 0.5 to ET, performed on the next operative day, or to conventional therapy (CON), which consisted of continued endotracheal intubation as needed, with tracheostomy (TRACH) performed on postburn day (PBD) 14 if necessary. During this period, 44 patients were randomized, 23 to CON and 21 to ET. Groups did not differ in age, total burn size, or inhalation injury, although ET patients had larger full-thickness burns. ET patients underwent TRACH at a mean of PBD 4 vs PBD 14.8 for CON patients (P <.01). ET patients had a significant improvement in PaO2 /FiO2 ratios within 24 hours following TRACH (139 +/- 15 vs 190 +/- 12; P <.01). There were no differences in ventilator support, length of stay, incidence of pneumonia, or survival. However, six CON patients (26%) were successfully extubated by PBD 14 compared with one ET patient (P <.01). Although tracheostomy offers some advantages in terms of patient comfort and security, routine performance of ET in burn patients does not improve outcomes, nor does it result in earlier extubation. This may be partly caused by the comfort and convenience of tracheostomy.