TRACHUS
Trial question
Is ultrasound-guided percutaneous dilational tracheostomy noninferior to bronchoscopy-guided percutaneous dilational tracheostomy in mechanically ventilated critically ill patients?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
31.0% female
69.0% male
N = 118
118 patients (37 female, 81 male).
Inclusion criteria: adult, intubated, mechanically ventilated patients with an indication for tracheostomy.
Key exclusion criteria: unsuitable anatomy to undergo a percutaneous dilational tracheostomy as judged by the attending physician; inability to get a written informed consent.
Interventions
N=60 ultrasound guidance (ultrasound-guided percutaneous dilational tracheostomy).
N=58 bronchoscopy guidance (bronchoscopy-guided percutaneous dilational tracheostomy).
Primary outcome
Procedure failure
1.7%
1.7%
1.7 %
1.3 %
0.8 %
0.4 %
0.0 %
Ultrasound
guidance
Bronchoscopy
guidance
Difference not exceeding
non-inferiority
margin ✓
Difference not exceeding non-inferiority margin in procedure failure (1.7% vs. 1.7%).
Secondary outcomes
No significant difference in procedure length (11 min vs. 13 min; AD -2 min, 95% CI -7.29 to 3.29).
No significant difference in ventilator-free days at day 60 (38.5 days vs. 38 days; AD 0.5 days, 95% CI -0.94 to 1.94).
No significant difference in death in the hospital (44.8% vs. 46.4%; ARD -1.6, 95% CI -18.63 to 15.43).
Safety outcomes
No significant difference in minor procedure-related complications.
Conclusion
In adult, intubated, mechanically ventilated patients with an indication for tracheostomy, ultrasound guidance was noninferior to bronchoscopy guidance with respect to procedure failure.
Reference
André Luiz Nunes Gobatto, Bruno A M P Besen, Paulo F G M M Tierno et al. Ultrasound-guided percutaneous dilational tracheostomy versus bronchoscopy-guided percutaneous dilational tracheostomy in critically ill patients (TRACHUS): a randomized noninferiority controlled trial. Intensive Care Med. 2016 Mar;42(3):342-351.
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