Intensive Care Medicine

, Volume 42, Issue 3, pp 342–351

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

  • 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
Original

DOI: 10.1007/s00134-016-4218-6

Cite this article as:
Gobatto, A.L.N., Besen, B.A.M.P., Tierno, P.F.G.M.M. et al. Intensive Care Med (2016) 42: 342. doi:10.1007/s00134-016-4218-6

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.

Keywords

Ultrasound Tracheostomy Bronchoscopy 

Abbreviations

CAPPesq

Comissão de Ética para Análise de Projetos de Pesquisa

CNS

Central nervous system

FiO2

Fraction of inspired oxygen

ICU

Intensive care unit

MV

Mechanical ventilation

NA

Not applicable

PaO2

Arterial oxygen pressure

PDT

Percutaneous dilational tracheostomy

RCT

Randomized clinical trial

SAPS 3

Simplified Acute Physiology Score 3

US

Ultrasound

Supplementary material

134_2016_4218_MOESM1_ESM.pdf (513 kb)
Supplementary material 1 (PDF 513 kb)

Copyright information

© Springer-Verlag Berlin Heidelberg and ESICM 2016

Authors and Affiliations

  • André Luiz Nunes Gobatto
    • 1
    • 4
  • Bruno A. M. P. Besen
    • 1
  • Paulo F. G. M. M. Tierno
    • 2
  • Pedro V. Mendes
    • 1
  • Filipe Cadamuro
    • 2
  • Daniel Joelsons
    • 3
  • Livia Melro
    • 1
  • Maria J. C. Carmona
    • 4
  • Gregorio Santori
    • 5
  • Paolo Pelosi
    • 5
    • 6
  • Marcelo Park
    • 1
  • Luiz M. S. Malbouisson
    • 2
    • 4
  1. 1.Medical Intensive Care Unit, Emergency Department, Hospital das ClínicasUniversity of São Paulo Medical SchoolSão PauloBrazil
  2. 2.Trauma Intensive Care Unit, Surgery Emergency Department, Hospital das ClínicasUniversity of São Paulo Medical SchoolSão PauloBrazil
  3. 3.Intensive Care Unit, Infectious Disease Department, Hospital das ClínicasUniversity of São Paulo Medical SchoolSão PauloBrazil
  4. 4.Surgical Intensive Care Unit, Anesthesiology Department, Hospital das ClínicasUniversity of São Paulo Medical SchoolSão PauloBrazil
  5. 5.Department of Surgical Sciences and Integrated DiagnosticsUniversity of GenoaGenoaItaly
  6. 6.Department of Surgical Sciences and Integrated DiagnosticsIRCCS AOU San Martino ISTGenoaItaly