A prospective open randomized controlled study was performed to assess the ability of Euromedical ILM endotracheal tube cuff (silicone cuff) to prevent pulmonary aspiration. The inflation characteristics of this silicone cuff enables the control of tracheal wall pressure. The silicone cuffed tube was shortened and an adjustable flange was used to convert it to a cuffed tracheostomy tube. Twelve patients requiring a tracheostomy on a four-bed intensive care unit (ICU) in a district general hospital received either a silicone or a Shiley cuffed tracheostomy tube. Tracheal wall pressures of both cuffs were maintained at 30 cm H2O with a constant pressure inflation device. Blue food dye was instilled once daily into the subglottic space through a fine catheter above the cuff. There were six patients in the Shiley group and six patients in the silicone cuff group. Dye leaked to the trachea in six (100%) of the Shiley group compared with none (0%) of the silicone cuff group (P = 0.001). This study confirms the effectiveness of this silicone cuff at preventing aspiration and the high incidence of leakage with the conventional high-volume low-pressure tracheostomy tube cuff.