Intensive Care Medicine

, Volume 42, Issue 3, pp 342–351 | Cite as

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

  • André Luiz Nunes GobattoEmail author
  • 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
  • Luiz M. S. Malbouisson



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.


Ultrasound Tracheostomy Bronchoscopy 



Comissão de Ética para Análise de Projetos de Pesquisa


Central nervous system


Fraction of inspired oxygen


Intensive care unit


Mechanical ventilation


Not applicable


Arterial oxygen pressure


Percutaneous dilational tracheostomy


Randomized clinical trial


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.

Supplementary material

134_2016_4218_MOESM1_ESM.pdf (513 kb)
Supplementary material 1 (PDF 513 kb)


  1. 1.
    Vargas M, Sutherasan Y, Antonelli M, Brunetti I, Corcione A, Laffey JG, Putensen C, Servillo G, Pelosi P (2015) Tracheostomy procedures in the intensive care unit: an international survey. Crit Care 19:291CrossRefGoogle Scholar
  2. 2.
    Delaney A, Bagshaw SM, Nalos M (2006) Percutaneous dilatational tracheostomy versus surgical tracheostomy in critically ill patients: a systematic review and meta-analysis. Critical Care 10: R55CrossRefGoogle Scholar
  3. 3.
    Putensen C, Theuerkauf N, Guenther U, Vargas M, Pelosi P (2014) Percutaneous and surgical tracheostomy in critically ill adult patients: a meta-analysis. Crit Care 18:544CrossRefGoogle Scholar
  4. 4.
    Dennis BM, Eckert MJ, Gunter OL, Morris JA Jr, May AK (2013) Safety of bedside percutaneous tracheostomy in the critically ill: evaluation of more than 3,000 procedures. J Am Coll Surg 216:858–865 (discussion 865–857)CrossRefGoogle Scholar
  5. 5.
    Hinerman R, Alvarez F, Keller CA (2000) Outcome of bedside percutaneous tracheostomy with bronchoscopic guidance. Intensive Care Med 26:1850–1856CrossRefGoogle Scholar
  6. 6.
    Fernandez L, Norwood S, Roettger R, Gass D, Wilkins H 3rd (1996) Bedside percutaneous tracheostomy with bronchoscopic guidance in critically ill patients. Arch Surg 131:129–132CrossRefGoogle Scholar
  7. 7.
    Flint AC, Midde R, Rao VA, Lasman TE, Ho PT (2009) Bedside ultrasound screening for pretracheal vascular structures may minimize the risks of percutaneous dilatational tracheostomy. Neurocrit Care 11:372–376CrossRefGoogle Scholar
  8. 8.
    Singh M, Chin KJ, Chan VW, Wong DT, Prasad GA, Yu E (2010) Use of sonography for airway assessment: an observational study. J Ultrasound Med 29:79–85CrossRefGoogle Scholar
  9. 9.
    Bonde J, Nørgaard N, Antonsen K (1999) Implementation of percutaneous dilation tracheotomy—value of preincisional ultrasonic examination? Acta Anaesthesiol Scand 43:163–166CrossRefGoogle Scholar
  10. 10.
    Kollig E, Heydenreich U, Roetman B, Hopf F, Muhr G (2000) Ultrasound and bronchoscopic controlled percutaneous tracheostomy on trauma ICU. Injury 31:663–668CrossRefGoogle Scholar
  11. 11.
    Sustic A, Zupan Z, Eskinja N, Dirlic A, Bajek G (1999) Ultrasonographically guided percutaneous dilatational tracheostomy after anterior cervical spine fixation. Acta Anaesthesiol Scand 43:1078–1080CrossRefGoogle Scholar
  12. 12.
    Rajajee V, Fletcher JJ, Rochlen LR, Jacobs TL (2011) Real-time ultrasound-guided percutaneous dilatational tracheostomy: a feasibility study. Crit Care 15:R67CrossRefGoogle Scholar
  13. 13.
    Rezende-Neto JB, Oliveira AJ, Neto MP, Botoni FA, Rizoli SB (2011) A technical modification for percutaneous tracheostomy: prospective case series study on one hundred patients. World J Emerg Surg 6:35CrossRefGoogle Scholar
  14. 14.
    Guinot PG, Zogheib E, Petiot S, Marienne JP, Guerin AM, Monet P, Zaatar R, Dupont H (2012) Ultrasound-guided percutaneous tracheostomy in critically ill obese patients. Crit Care 16:R40CrossRefGoogle Scholar
  15. 15.
    Rajajee V, Williamson CA, West BT (2015) Impact of real-time ultrasound guidance on complications of percutaneous dilatational tracheostomy—a propensity score analysis. Crit Care 19:198CrossRefGoogle Scholar
  16. 16.
    Gobatto AL, Besen BA, Tierno PF, Mendes PV, Cadamuro F, Joelsons D, Melro L, Park M, Malbouisson LM (2015) Comparison between ultrasound- and bronchoscopy-guided percutaneous dilational tracheostomy in critically ill patients: a retrospective cohort study. J Crit Care 30:220.e213–220.e227CrossRefGoogle Scholar
  17. 17.
    Yavuz A, Yilmaz M, Goya C, Alimoglu E, Kabaalioglu A (2014) Advantages of US in percutaneous dilatational tracheostomy: randomized controlled trial and review of the literature. Radiology 273:927–936CrossRefGoogle Scholar
  18. 18.
    Rudas M, Seppelt I, Herkes R, Hislop R, Rajbhandari D, Weisbrodt L (2014) Traditional landmark versus ultrasound guided tracheal puncture during percutaneous dilatational tracheostomy in adult intensive care patients: a randomised controlled trial. Crit Care 18:514CrossRefGoogle Scholar
  19. 19.
    Ravi PR, Vijay MN (2015) Real time ultrasound-guided percutaneous tracheostomy: is it a better option than bronchoscopic guided percutaneous tracheostomy? Med J Armed Forces India 71:158–164CrossRefGoogle Scholar
  20. 20.
    Jackson LS, Davis JW, Kaups KL, Sue LP, Wolfe MM, Bilello JF, Lemaster D (2011) Percutaneous tracheostomy: to bronch or not to bronch–that is the question. J Trauma 71:1553–1556CrossRefGoogle Scholar
  21. 21.
    Abdulla S, Conrad A, Vielhaber S, Eckhardt R, Abdulla W (2013) Should a percutaneous dilational tracheostomy be guided with a bronchoscope? B-ENT 9:227–234PubMedGoogle Scholar
  22. 22.
    Schuirmann DJ (1987) A comparison of the two one-sided tests procedure and the power approach for assessing the equivalence of average bioavailability. J Pharmacokinet Biopharm 15:657–680CrossRefGoogle Scholar
  23. 23.
    Walker E, Nowacki AS (2011) Understanding equivalence and noninferiority testing. J Gen Intern Med 26:192–196CrossRefGoogle Scholar
  24. 24.
    Rudas M, Seppelt I (2012) Safety and efficacy of ultrasonography before and during percutaneous dilatational tracheostomy in adult patients: a systematic review. Crit Care Resusc 14:297–301PubMedGoogle Scholar
  25. 25.
    Alansari M, Alotair H, Al Aseri Z, Elhoseny MA (2015) Use of ultrasound guidance to improve the safety of percutaneous dilatational tracheostomy: a literature review. Critical Care 19:229CrossRefGoogle Scholar
  26. 26.
    Madsen KR, Guldager H, Rewers M, Weber SO, Kobke-Jacobsen K, White J (2015) Danish guidelines 2015 for percutaneous dilatational tracheostomy in the intensive care unit. Dan Med J 61(3):pii B5042 Google Scholar
  27. 27.
    Kornblith LZ, Burlew CC, Moore EE, Haenel JB, Kashuk JL, Biffl WL, Barnett CC, Johnson JL (2011) One thousand bedside percutaneous tracheostomies in the surgical intensive care unit: time to change the gold standard. J Am Coll Surg 212:163–170CrossRefGoogle Scholar
  28. 28.
    Higgins KM, Punthakee X (2007) Meta-analysis comparison of open versus percutaneous tracheostomy. Laryngoscope 117:447–454CrossRefGoogle Scholar
  29. 29.
    Park M, Brauer L, Sanga RR, Amaral ACK-B, Ladeira JP, Azevedo LCPd, Taniguchi LU, Cruz-Neto LMd (2004) Traqueostomia percutânea no doente crítico: a experiência de uma unidade de terapia intensiva clínica. J Bras Pneumol 30:237–242CrossRefGoogle Scholar
  30. 30.
    Polderman KH, Spijkstra JJ, de Bree R, Christiaans HM, Gelissen HP, Wester JP, Girbes AR (2003) Percutaneous dilatational tracheostomy in the ICU: optimal organization, low complication rates, and description of a new complication. Chest 123:1595–1602CrossRefGoogle Scholar
  31. 31.
    Tomsic JP, Connolly MC, Joe VC, Wong DT (2006) Evaluation of bronchoscopic-assisted percutaneous tracheostomy. Am Surg 72:970–972PubMedGoogle Scholar
  32. 32.
    Kluge S, Baumann HJ, Maier C, Klose H, Meyer A, Nierhaus A, Kreymann G (2008) Tracheostomy in the intensive care unit: a nationwide survey. Anesth Analg 107:1639–1643CrossRefGoogle Scholar
  33. 33.
    Kost KM (2005) Endoscopic percutaneous dilatational tracheotomy: a prospective evaluation of 500 consecutive cases. Laryngoscope 115:1–30CrossRefGoogle Scholar
  34. 34.
    Dinh VA, Farshidpanah S, Lu S, Stokes P, Chrissian A, Shah H, Giri P, Hecht D, Nguyen HB (2014) Real-time sonographically guided percutaneous dilatational tracheostomy using a long-axis approach compared to the landmark technique. J Ultrasound Med 33:1407–1415CrossRefGoogle Scholar
  35. 35.
    Chacko J, Gagan B, Kumar U, Mundlapudi B (2015) Real-time ultrasound guided percutaneous dilatational tracheostomy with and without bronchoscopic control: an observational study. Minerva Anestesiol 81:166–174PubMedGoogle Scholar
  36. 36.
    Chacko J, Nikahat J, Gagan B, Umesh K, Ramanathan M (2012) Real-time ultrasound-guided percutaneous dilatational tracheostomy. Intensive Care Med 38:920–921CrossRefGoogle Scholar
  37. 37.
    Siegel JP (2000) Equivalence and noninferiority trials. Am Heart J 139:S166–S170CrossRefGoogle Scholar
  38. 38.
    Snapinn SM (2004) Alternatives for discounting in the analysis of noninferiority trials. J Biopharm Stat 14:263–273CrossRefGoogle Scholar
  39. 39.
    Stevenson AR, Solomon MJ, Lumley JW, Hewett P, Clouston AD, Gebski VJ, Davies L, Wilson K, Hague W, Simes J, ALaCaRT Investigators (2015) Effect of laparoscopic-assisted resection vs open resection on pathological outcomes in rectal cancer: the ALaCaRT randomized clinical trial. JAMA 314:1356–1363CrossRefGoogle Scholar
  40. 40.
    Bonjer HJ, Deijen CL, Haglind E, COLOR II Study Group (2015) A randomized trial of laparoscopic versus open surgery for rectal cancer. N Engl J Med 373:194PubMedGoogle Scholar

Copyright information

© Springer-Verlag Berlin Heidelberg and ESICM 2016

Authors and Affiliations

  • André Luiz Nunes Gobatto
    • 1
    • 4
    Email author
  • Bruno A. M. P. Besen
    • 1
  • Paulo F. G. M. M. Tierno
    • 2
  • Pedro V. Mendes
    • 1
  • Filipe Cadamuro
    • 2
  • Daniel Joelsons
    • 3
  • Livia Melro
    • 1
  • Maria J. C. Carmona
    • 4
  • Gregorio Santori
    • 5
  • Paolo Pelosi
    • 5
    • 6
  • Marcelo Park
    • 1
  • Luiz M. S. Malbouisson
    • 2
    • 4
  1. 1.Medical Intensive Care Unit, Emergency Department, Hospital das ClínicasUniversity of São Paulo Medical SchoolSão PauloBrazil
  2. 2.Trauma Intensive Care Unit, Surgery Emergency Department, Hospital das ClínicasUniversity of São Paulo Medical SchoolSão PauloBrazil
  3. 3.Intensive Care Unit, Infectious Disease Department, Hospital das ClínicasUniversity of São Paulo Medical SchoolSão PauloBrazil
  4. 4.Surgical Intensive Care Unit, Anesthesiology Department, Hospital das ClínicasUniversity of São Paulo Medical SchoolSão PauloBrazil
  5. 5.Department of Surgical Sciences and Integrated DiagnosticsUniversity of GenoaGenoaItaly
  6. 6.Department of Surgical Sciences and Integrated DiagnosticsIRCCS AOU San Martino ISTGenoaItaly

Personalised recommendations