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Intensive Care Medicine
Published in: Intensive Care Medicine 3/2016

01-03-2016 | Original

Ultrasound-guided percutaneous dilational tracheostomy versus bronchoscopy-guided percutaneous dilational tracheostomy in critically ill patients (TRACHUS): a randomized noninferiority controlled trial

Authors: 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

Published in: Intensive Care Medicine | Issue 3/2016

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Abstract

Purpose

Percutaneous dilational tracheostomy (PDT) is routinely performed in the intensive care unit with bronchoscopy guidance. Recently, ultrasound has emerged as a potentially useful tool to assist PDT and reduce procedure-related complications.

Methods

An open-label, parallel, non-inferiority randomized controlled trial was conducted comparing an ultrasound-guided PDT with a bronchoscopy-guided PDT in mechanically ventilated critically ill patients. The primary outcome was procedure failure, defined as a composite end-point of conversion to a surgical tracheostomy, unplanned associated use of bronchoscopy or ultrasound during PDT, or the occurrence of a major complication.

Results

A total of 4965 patients were assessed for eligibility. Of these, 171 patients were eligible and 118 underwent the procedure, with 60 patients randomly assigned to the ultrasound group and 58 patients to the bronchoscopy group. Procedure failure occurred in one (1.7 %) patient in the ultrasound group and one (1.7 %) patient in the bronchoscopy group, with no absolute risk difference between the groups (90 % confidence interval, −5.57 to 5.85), in the “as treated” analysis, not including the prespecified margin of 6 % for noninferiority. No other patient had any major complication in either group. Procedure-related minor complications occurred in 20 (33.3 %) patients in the ultrasound group and in 12 (20.7 %) patients in the bronchoscopy group (P = 0.122). The median procedure length was 11 [7–19] vs. 13 [8–20] min (P = 0.468), respectively, and the clinical outcomes were also not different between the groups.

Conclusions

Ultrasound-guided PDT is noninferior to bronchoscopy-guided PDT in mechanically ventilated critically ill patients.
Appendix
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Metadata
Title
Ultrasound-guided percutaneous dilational tracheostomy versus bronchoscopy-guided percutaneous dilational tracheostomy in critically ill patients (TRACHUS): a randomized noninferiority controlled trial
Authors
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
Publication date
01-03-2016
Publisher
Springer Berlin Heidelberg
Published in
Intensive Care Medicine / Issue 3/2016
Print ISSN: 0342-4642
Electronic ISSN: 1432-1238
DOI
https://doi.org/10.1007/s00134-016-4218-6

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