title: Ultrasound-guided percutaneous dilational tracheostomy versus bronchoscopy-guided percutaneous dilational tracheostomy in critically ill patients (TRACHUS): a randomized noninferiority controlled trial.
abstract: OBJECTIVE
  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.
authors.affiliation: 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.|Surgical Intensive Care Unit, Anesthesiology Department, Hospital das Clínicas, University of São Paulo Medical School, São Paulo, Brazil. andregobatto@gmail.com.
authors.forename: André Luiz Nunes
authors.initials: ALN
authors.lastname: Gobatto
authors.affiliation: 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.
authors.forename: Bruno A M P
authors.initials: BAMP
authors.lastname: Besen
authors.affiliation: Trauma Intensive Care Unit, Surgery Emergency Department, Hospital das Clínicas, University of São Paulo Medical School, São Paulo, Brazil.
authors.forename: Paulo F G M M
authors.initials: PFGMM
authors.lastname: Tierno
authors.affiliation: 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.
authors.forename: Pedro V
authors.initials: PV
authors.lastname: Mendes
authors.affiliation: Trauma Intensive Care Unit, Surgery Emergency Department, Hospital das Clínicas, University of São Paulo Medical School, São Paulo, Brazil.
authors.forename: Filipe
authors.initials: F
authors.lastname: Cadamuro
authors.affiliation: Intensive Care Unit, Infectious Disease Department, Hospital das Clínicas, University of São Paulo Medical School, São Paulo, Brazil.
authors.forename: Daniel
authors.initials: D
authors.lastname: Joelsons
authors.affiliation: 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.
authors.forename: Livia
authors.initials: L
authors.lastname: Melro
authors.affiliation: Surgical Intensive Care Unit, Anesthesiology Department, Hospital das Clínicas, University of São Paulo Medical School, São Paulo, Brazil.
authors.forename: Maria J C
authors.initials: MJC
authors.lastname: Carmona
authors.affiliation: Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.
authors.forename: Gregorio
authors.initials: G
authors.lastname: Santori
authors.affiliation: Department of Surgical Sciences and Integrated Diagnostics, University of Genoa, Genoa, Italy.|Department of Surgical Sciences and Integrated Diagnostics, IRCCS AOU San Martino IST, Genoa, Italy.
authors.forename: Paolo
authors.initials: P
authors.lastname: Pelosi
authors.affiliation: 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.
authors.forename: Marcelo
authors.initials: M
authors.lastname: Park
authors.affiliation: Trauma Intensive Care Unit, Surgery Emergency Department, Hospital das Clínicas, University of São Paulo Medical School, São Paulo, Brazil.|Surgical Intensive Care Unit, Anesthesiology Department, Hospital das Clínicas, University of São Paulo Medical School, São Paulo, Brazil.
authors.forename: Luiz M S
authors.initials: LMS
authors.lastname: Malbouisson
mesh_terms: D001999:Bronchoscopy / Q000379:methods*; D016638:Critical Illness; D005260:Female; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D014139:Tracheostomy / Q000379:methods*; D016896:Treatment Outcome; D018084:Ultrasonography, Interventional / Q000379:methods*
keywords: Bronchoscopy; Tracheostomy; Ultrasound
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