• Eur J Anaesthesiol · Sep 2011

    Clinical Trial

    Evaluation of the Bonfils intubating fibrescope for predicted difficult intubation in awake patients with ear, nose and throat cancer.

    • Jean E Mazères, Anne Lefranc, Claire Cropet, Aline Steghens, Patrick Bachmann, Olivia Pérol, and Hervé Rosay.
    • Department of Anaesthesiology and Intensive Care Medicine, Centre Léon Bérard, Lyon, France. mazeres@lyon.fnclcc.fr
    • Eur J Anaesthesiol. 2011 Sep 1;28(9):646-50.

    Background And ObjectiveAnaesthesiologists 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.MethodsIntubation 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.ResultsBetween 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.ConclusionTracheal 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.Clinical Trial Registration NumberNCT01070537, URL: http://clinicaltrials.gov/ct2/show/NCT01070537?term=bonfils&rank=2.

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