Ultrasound-guided percutaneous dilational tracheostomy versus bronchoscopy-guided percutaneous dilational tracheostomy in critically ill patients (TRACHUS): a randomized noninferiority controlled trial
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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.
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.
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.
Ultrasound-guided PDT is noninferior to bronchoscopy-guided PDT in mechanically ventilated critically ill patients.
KeywordsUltrasound Tracheostomy Bronchoscopy
Comissão de Ética para Análise de Projetos de Pesquisa
Central nervous system
Fraction of inspired oxygen
Intensive care unit
Arterial oxygen pressure
Percutaneous dilational tracheostomy
Randomized clinical trial
- SAPS 3
Simplified Acute Physiology Score 3
We would like to thank the nursing staff, the respiratory therapists, the intensive care medicine residents, and all of the attending physicians from the ICU departments for performing treatment for our patients and for their cooperation in the trial. Special acknowledgments are due to Dr. Mino Cestari whose collaboration was indispensable to the trial.
Compliance with ethical standards
Conflicts of interests
The authors have no relevant conflict of interest to disclose. The study was not financially supported by any funding source. The design, collection, analysis, and the interpretation of data, plus the writing and the publication of the manuscript, were done by the authors without participation or influence from any funding source.
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