ABSTRACT
Cuff pressure gauges are the only recommended instrument to perform controls on endotracheal tube cuff pressure during anesthesia. No calibration is mandatory for these devices. The aim of this study was to describe the level of conformity of various cuff pressure gauges. The single-center measurements were performed with a cuff pressure calibrator on all cuff pressure gauges that were usually used in the operating room. Seven measurements (repeat three times) on each cuff pressure gauges at different levels of pressures (i.e. 0, 10, 20, 27, 30, 40 and 50 cmH2O) were performed. Our homologation criteria were either the reliability of the leak test (value of cuff pressure gauges maintained at 120 cmH2O during 5 s) or the difference between the values of the cuff pressure tested and the calibrator below 1.3 cmH2O at the range of 20-30 cmH2O. A total of 567 measurements on 27 cuff pressure gauges were performed. Only 30% (n = 8/27) of the cuff pressure gauges reach our homologation criteria. 30% (n = 8/27) failed at the leak test. 48% (n = 13/27) of the cuff pressure gauges tested, had a calibration variation error > 1.3 cmH2O on the levels of pressure between 20 and 30 cmH2O. A minority of cuff pressure gauges went through our homologation criteria. These results demonstrate us that there is a real problem of the reliability and the follow-up of those medical devices. This study suggests to reinforce biomedical engineering control on these devices.
