| Summary: | <p>Abstract</p> <p>Background</p> <p>The Lotrach endotracheal tube has a unique low-volume, low-pressure (LVLP) cuff, which has been designed to prevent pressure injury to the tracheal wall. We aimed to estimate the pressure exerted on the tracheal wall by the LVLP cuff and a conventional cuff in a bench-top, clinical and radiological study.</p> <p>Method</p> <p>In the bench-top study, a model trachea was intubated with the LVLP cuff and the conventional cuff. The cuff pressure was controlled using a constant pressure device. We assessed the pressure exerted on the tracheal wall by measuring the ability of the cuffs to support a column of water using a standard protocol. In the clinical study, we tested the ability of both cuffs to prevent air leak during a staged recruitment manoeuvre. In the radiological study, we recorded the degree of anatomical distortion of the trachea from both cuffs in the antero-posterior (AP) and transverse tracheal diameters. We performed statistical analysis using non-inferiority tests.</p> <p>Results</p> <p>In the bench-top study, the LVLP cuff achieved a plateau at a mean height of 25.2 cmH2O (SD 0.34). In contrast, the conventional cuff failed to maintain any water above the cuff and a plateau could not be measured. In the clinical study, the mean pressure at which air leak occurred was 30.0 +/- 0.8 cmH2O (SD 3.8) using the LVLP cuff and 32.4 +/- 0.7 cmH2O (SD 3.0) using the conventional cuff. In the radiological study, the mean degree of anatomical distortion of the trachea in AP and transverse tracheal diameter was 2.9 +/- 2.2 mm (SD 2.1) and 1.8 +/- 1.4 mm (SD 1.4) using the LVLP cuff and 4.4 +/- 1.3 mm (SD 1.4) and 2.6 +/- 1.5 mm (SD 1.6) using the conventional cuff.</p> <p>Conclusions</p> <p>The bench-top and clinical studies both demonstrated that the LVLP cuff exerted approximately 30 cmH2O of pressure on the tracheal wall. These results are supported by our radiological study. We conclude that the LVLP cuff exerts an acceptable amount of pressure on the tracheal wall when it is operated at the recommended intracuff pressure.</p>
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