Technological innovation device ‘DYNAtraq’ for the alignment and fixation of the tracheostomy cannula: Preliminary analysis of its efficacy and safety.

Abstract

<b>Introduction:</b> Incidence of complications derived from tracheostomy can range between 5% and 40%. They could be prevented using both a proper fixation and alignment of tracheostomy cannula. <b>Objective:</b> To evaluate efficacy and safety of technological and innovative device (DYNAtraq) for fixation and alignment of tracheostomy tubes in patients hospitalized in ICU receiving mechanical ventilation. <b>Methods:</b> Randomized controlled clinical trial, including 40 patients under mechanical ventilation via tracheostomy at the ICU of Fundación Cardiovascular de Colombia, twenty assigned to reference group and twenty to intervention group, using the device. Alignment was evaluated by measuring cephalocaudal and laterolateral angles using the SAPO angular measurement software. 90°±10° were refered as ideal position. Complications were evaluated by observation by trained health personnel, daily on a basis up to ventilatory weaning. <b>Results:</b> DYNAtraq reduced malposition by 80% for -latero-lateral angle (p&lt;0.001) and 60% for cephalo-caudal angle (p&lt;0.001). Its effect was maintained during all follow-up time (p&lt;0.001). There were no serious adverse events, and a protective effect was found for complications of 70% (RR=0.3, p&lt;0.001). <b>Conclusions:</b> DYNAtraq is effective to correct the alignment of tracheostomy tubes in ICU patients receiving mechanical ventilation.