• 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, and Luiz M S Malbouisson.
• Medical Intensive Care Unit, Emergency Department, Hospital das Clínicas, University of São Paulo Medical School, Rua Dr. Eneas Carvalho Aguiar, 255, Sixth Floor, Room 6040, São Paulo, Brazil. andregobatto@gmail.com.
• Intensive Care Med. 2016 Mar 1; 42 (3): 342-51.

PurposePercutaneous 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.MethodsAn 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.ResultsA 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.ConclusionsUltrasound-guided PDT is noninferior to bronchoscopy-guided PDT in mechanically ventilated critically ill patients.

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