TRACHUS

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

Gobatto. 2016; Mar;42(3):342-51. doi: 10.1007/s00134-016-4218-6

Clinical Question

  • Is ultrasound guided percutaneous tracheostomy (PCT) a non-inferior technique compared with bronchoscopy guided PCT?

Design

  • Prospective
  • Non-inferiority
  • Randomised control trial
  • Random permuted blocks using an automated third party internet based service
  • Non blinded
  • Sample size 114 patients: Power of 90%. 1.2 % rate of primary outcome in bronchoscopy PCT groups previously. Assuming absolute non-inferiority margin of 6% at one-sided alpha significance of 0.05

Setting

  • Single centre study
  • 8 ICUs in Sao Paulo University
  • March 2014 – May 2015

Population

  • Inclusion: Adult patients, intubated, mechanically ventilated and indicated for a tracheostomy
  • Exclusion: Unsuitable anatomy; short neck; tracheal deviation; cervical anomaly; previous cervical surgery; cervical trauma; cervical tumours; unable extend neck; inability to get written consent
  • 4965 assessed for eligibility. 171 patients eligible, 118 randomised
  • Well matched except SAPS score at ICU admission

Intervention

  • Ultrasound-guided PCT
    • Midline identified by transverse scan
    • Longitudinal plane 2nd/3rd ring
    • Real time puncture in transverse plane at midline

Control

  • Bronchoscopy guided PCT
    • Airway cartilages identified
    • 2nd/3rd space identified and punctured
    • Direct observation

Outcome

  • Primary outcome: No significant difference in composite outcome (conversion to surgical tracheostomy, switching groups or major complication) between US-guided PCT and bronchoscopy-guided PCT
    • major complications: death, cardiac arrest, tracheal wall injury, false passage, pneumothorax, pneumomediastinum, oesophageal injury, TOF, persistent hypotension, persistent acute hypoxaemia, major bleeding, tracheostomy sepsis
    • one failure in each group (1.7%)
      • US group – insertion between 5th and 6th tracheal ring leading to tracheal laceration and mediastinitis
      • Bronchoscopy group – insertion causing tracheal laceration and pneumomediastinum
  • Secondary outcome: No statistically significant difference in minor complications
    20 (33%) US group vs 12 (20.7%) bronchoscopy group; p=0.122

    • minor complications: procedural length, procedural difficulty, alive ventilator free days at 60 days, ICU mortality, Minor complications (transient hypotension, transient acute hypoxia, cuff puncture, decannulation, stoma infection, localised minor bleeding, localised emphysema)

Authors’ Conclusions

  • US-guided PCT is non-inferior to bronchoscopy-guided PCT in mechanically ventilated patients in the ICU

Strengths

  • Prospective randomisation
  • Allocation concealment
  • Limited exclusion criterion
  • High percentage of enrolments of eligible patients
  • The clinical outcomes were clinically relevant and the data analysis was blinded

Weaknesses

  • Single-center investigation
  • Composite primary end point and small sample number to detect complications
  • Non-inferiority margin of 6 % might be considerably high for the low primary outcome incidence rate
  • Followed only until hospital discharge and were not assessed for late complications such as tracheal stenosis, vocal abnormalities, or scar characteristics
  • Blinding was not possible
  • Larger study to detect minor complications may have shown significance

The Bottom Line

  • US-guided was not inferior to bronchoscopy-guided PCT. Although the study was underpowered to detect differences for minor complications (50% more in the US group)
  • Ultrasound has been shown to be useful to aid placement of a percutaneous tracheostomy. I will now use ultrasound to aid landmark identification of the correct tracheal space
  • However, this study has not completely changed my practice. I will continue to use ultrasound and bronchoscopy for my percutaneous tracheostomies because of their distinct safety features. Ultrasound can detect vessels and thyroid beneath the puncture site and potentially avoid significant haemorrhage. Bronchoscopy can detect oesophageal perforations with the needle prior to dilatation. Why choose between bronchoscopy and ultrasound when we can use both?

External Links

Metadata

Summary author: Phil McGlone
Summary date: March 7th 2016
Peer-review editor: Celia Bradford

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