A new design of tracheal tube cuff, the pressure-limited cuff, used with a constant-pressure inflation system, was compared with a high-volume low-pressure cuffed tracheal tube for leakage of dye placed in the subglottic space into the trachea. Patients requiring ventilation on the intensive care unit were randomly allocated into two groups, one for each type of cuff, and blue food dye was instilled daily via a fine catheter above the cuff into the subglottic space. There were eight patients in the high-volume low-pressure group and seven in the pressure-limited cuff group. Dye leaked into the trachea in seven (87%) of the high-volume low-pressure group compared with none (0%) of the pressure-limited cuff group (p < 0.01). This study demonstrates that the pressure-limited cuffed tracheal tube, in combination with a constant-pressure inflation device, prevents leakage of fluid into the lungs that occurs with high-volume low-pressure cuffs in the critically ill, intubated patient.