title: Evaluation of the Bonfils intubating fibrescope for predicted difficult intubation in awake patients with ear, nose and throat cancer.
abstract: OBJECTIVE
  Anaesthesiologists are regularly faced with difficult tracheal intubation. The objective of the study was to evaluate the feasibility and tolerability of tracheal intubation with the Bonfils intubating fibrescope in awake adult patients with predicted difficult intubation undergoing cancer surgery in an ear, nose and throat unit.
  
  
  METHODS
  Intubation was performed under local anaesthesia and remifentanil sedation with spontaneous ventilation. The primary endpoint was the proportion of intubations which met the following quality requirements: successful intubation (≤ 2 attempts and duration <180 s) and good tolerability (Fahey scale <2). Secondary endpoints included the operational problems encountered and patients' perception of the procedure immediately and 7 days after the intervention. Using a one-stage Fleming design, 32 patients were required to complete the study. Forty-one eligible adult patients were enrolled.
  
  
  RESULTS
  Between February 2008 and March 2009, the primary endpoint could be evaluated in 33 patients. Quality requirements were met in 26 patients (78.8%) and not met in seven patients (five were intubated with the Bonfils fibrescope and two using another technique). Difficulties were reported in 13 patients (39.4%). Eighty-four percent of the patients had a good or very good perception of the intubation shortly after the procedure, and 91% after 7 days.
  
  
  CONCLUSIONS
  Tracheal intubation using the Bonfils intubating fibrescope was successful in almost all patients (93.9%). The 78.8% incidence of interventions which met the quality requirements is high in the context of ear, nose and throat cancer and acceptable in current clinical practice. In ear, nose and throat cancer patients who do not require nasopharyngeal intubation and in whom orotracheal intubation is predicted to be difficult, the use of the Bonfils intubating fibrescope is safe, effective and well tolerated.
  
  
  BACKGROUND
  NCT01070537, URL: http://clinicaltrials.gov/ct2/show/NCT01070537?term=bonfils&rank=2.
authors: Department of Anaesthesiology and Intensive Care Medicine, Centre Léon Bérard, Lyon, France. mazeres@lyon.fnclcc.fr
authors: Jean E
authors: JE
authors: Mazères
authors: Anne
authors: A
authors: Lefranc
authors: Claire
authors: C
authors: Cropet
authors: Aline
authors: A
authors: Steghens
authors: Patrick
authors: P
authors: Bachmann
authors: Olivia
authors: O
authors: Pérol
authors: Hervé
authors: H
authors: Rosay
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004428:Ear Neoplasms / Q000601:surgery*; D005240:Feasibility Studies; D005260:Female; D005336:Fiber Optic Technology; D005500:Follow-Up Studies; D006801:Humans; D007442:Intubation, Intratracheal / Q000009:adverse effects / Q000295:instrumentation / Q000379:methods*; D008297:Male; D008875:Middle Aged; D009669:Nose Neoplasms / Q000601:surgery*; D010610:Pharyngeal Neoplasms / Q000601:surgery*; D011446:Prospective Studies; D013997:Time Factors