评估 Bonfils 插管纤维喉镜在清醒的耳鼻喉癌患者预测性困难插管中的应用。

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

机构信息

Department of Anaesthesiology and Intensive Care Medicine, Centre Léon Bérard, Lyon, France.

出版信息

Eur J Anaesthesiol. 2011 Sep;28(9):646-50. doi: 10.1097/EJA.0b013e3283495b85.

DOI:10.1097/EJA.0b013e3283495b85

PMID:21743336

Abstract

BACKGROUND AND 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.

CONCLUSION

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.

CLINICAL TRIAL REGISTRATION NUMBER

NCT01070537, URL: http://clinicaltrials.gov/ct2/show/NCT01070537?term=bonfils&rank=2.

摘要

背景和目的

麻醉师经常面临困难的气管插管。本研究的目的是评估 Bonfils 纤维支气管镜在清醒成人患者中进行气管插管的可行性和耐受性，这些患者预计在耳鼻喉科进行癌症手术时存在插管困难。

方法

在局部麻醉和瑞芬太尼镇静下进行插管，患者保持自主呼吸。主要终点是插管符合以下质量要求的比例：成功插管（≤2 次尝试且持续时间<180s）和良好的耐受性（Fahey 量表<2）。次要终点包括操作过程中遇到的问题以及患者在干预后即刻和 7 天的感知。使用单阶段 Fleming 设计，需要 32 名患者完成研究。共纳入 41 名符合条件的成年患者。

结果

2008 年 2 月至 2009 年 3 月，33 名患者可评估主要终点。26 名患者（78.8%）符合质量要求，7 名患者（5 名使用 Bonfils 纤维支气管镜插管，2 名使用其他技术）不符合质量要求。13 名患者（39.4%）报告有困难。84%的患者在手术后即刻对插管有良好或非常好的感觉，91%在 7 天后有良好或非常好的感觉。