Although percutaneous dilatational tracheostomy (PDT) has been shown to be a cost-effective bedside alternative to open tracheostomy (OT), prior reports of the complications of the procedure are contradictory. Reported complications range from minor events to fatal ones, in varying percentages. This prospective study was designed to identify the type and severity of complications accompanying the introduction of PDT to a tertiary medical center. Surgical and medical intensive care unit (ICU) patients requiring elective tracheostomy were identified as appropriate for PDT using approved institutional criteria. All procedures were performed at an ICU bedside in the presence of a surgeon privileged to perform OT. Demographic data, procedural information, and patient outcome (including minor and major complications, length of stay, and survival) were collected. PDT was performed in 96 ICU patients, with complete data available for 95 patients. PDT was performed in an average of 13.1+/-1.0 minutes. Twenty-three major and minor complications occurred, including two perioperative deaths, in 15 patients (15.8%). A total of 37 PDT patients (38.9%) died in the hospital, indicative of the severity of illness of patients requiring tracheostomy. Based on the experience to date, Cedars-Sinai Medical Center (Los Angeles, CA) continues to require a surgeon privileged to perform OT to participate in all PDT procedures.