ARTICLE REVIEW ~ The TRACHUS Trial
Tracheostomy is a procedure performed to replace endotracheal intubation in patients expected to undergo long-term mechanical ventilation. Percutaneous dilational tracheostomy (PDT) is now widely diffused as a safe and easy procedure to be performed in ICU by trained nonsurgical specialists. Bronchoscopy guidance is frequently adopted as a safety measure, since it is of support in the choice of the correct point of puncture guiding the real-time entrance of the needle and avoiding posterior tracheal wall lesions. Recently, ultrasound (US) guidance has been proposed as tool to improve the safety of the procedure. The advantages of its use mainly consist in better identifying cervical vessels and thyroid glands along with guiding the choice of tracheal puncture site, tube size and length selection. However, up to now, available evidence regarding the feasibility and safety of this technique consists in case series or observational investigations.
The authors of this paper performed an open-label, parallel, non inferiority randomised controlled trial to compare US-guided PDT with bronchoscopy PDT in mechanically ventilated critically ill patients. Procedure failure was chosen as composite primary endpoint including conversion to a surgical tracheostomy, associated use of bronchoscopy/US or the occurrence of major complications (i.e. haemodynamic instability, hypoxemia, anatomic injuries, bleeding). The occurrence of minor complications, procedure length, procedure difficulty (on 5-steps scale from easy to impossible), and liberation from mechanical ventilation were considered secondary outcomes. One-hundred eighteen patients underwent the procedure and were included in the analysis: 60 assigned to US and 58 to bronchoscopy. In both ‘as treated’ and ‘intention-to-treat’ analyses the absolute risk difference between the groups for the primary outcome was none. One patient in both groups experienced tracheal laceration with mediastinitis/pneumomediastinum. Most frequently observed minor complications were transient hypotension and minor bleeding, with a non significant higher percentage of adverse events in the US group (33.3% vs. 20.7%, p=0.12), persisting after an adjusted analysis for the SAPS 3 score (p=0.148). In addition the percentage of patients achieving unassisted breathing, the ventilation-free days and the time from tracheostomy to unassisted breathing did not significantly differ between the two groups. Finally in about 85% of the cases the procedure was considered ‘easy’ or ‘somewhat difficult’ and ‘very difficult’ only in one patient per group. However, despite such interesting results, some limitations should be addressed, in particular the single centre and unblind design and the absence of late complications monitoring.
Take Home Message
Ultrasound guidance may be safely and effectively used by skilled ICU physicians for performing dilational percutaneous tracheostomy. Large scale use and long-term complications of this new approach need further investigations.
This article review was prepared by Gennaro De Pascale on behalf of the NEXT Committee.
André Luiz Nunes Gobatto, Bruno A. M. P. Besen, Paulo F. G. M. M. Tierno, Pedro V. Mendes, Filipe Cadamuro, Daniel Joelsons, Livia Melro, Maria J. C. Carmona, Gregorio Santori, Paolo Pelosi, Marcelo Park, Luiz M. S. Malbouisson. Ultrasound-guided percutaneous dilational tracheostomy versus bronchoscopy-guided percutaneous dilational tracheostomy in critically ill patients (TRACHUS): a randomised noninferiority controlled trial. Intensive Care Med, Original; ONLINE FIRST February, 2016, Pages 1 – 10.