INVIBO: Evaluation of the Feasibility and Tolerance of an Intubation Procedure Performed by Means of the Bonfils Fiberscope in Awake Patients With Predicted Difficult Intubation in the Context of ENT Cancer Surgery
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 1
- 主要终点
- The rate of BFI meeting quality requirements: the procedure must be successful on the one hand (≤ 2 attempts and duration < 180 sec); and well tolerated on the other hand (Fahey score < 2).
研究概览
简要总结
The Bonfils intubation fiberscope (BF), a rigid medical device with a curved tip, is exclusively used in anesthesiology for orotracheal intubation (OTI). The objective of the study was to evaluate the feasibility and the tolerance of an intubation procedure realized by means of the BF (BFI) in awake adult patients with predicted difficult intubation (PDI), in the context of ENT cancer surgery.
The intubation is performed under local anesthesia (either nasal, oral, or intercricothyroidal) and sedation using Remifentanyl (AIVOC) with spontaneous ventilation. The primary endpoint is the rate of BFI meeting quality requirements: the procedure must be both successful (≤ 2 attempts and duration < 180 sec) and well tolerated (Fahey score < 2). The secondary endpoints include the difficulties met by the operator during the BFI and patient's perception of the intubation procedure, evaluated in the recovery room and 7 days after the intervention. Sample size is calculated using a one-stage Fleming design with p0=80%, p1=95%, alpha=5% and 80% power, for a total of 32 evaluable patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients aged ≥ 18 years
- •Requiring a surgical intervention for an ENT carcinoma
- •Presenting with a PDI defined either as an Arne Score > 11, or a previous history of DI or by the surgeon's judgment.
- •Able to understand, read and write French
- •Signed, written informed consent
排除标准
- •Impossible mask ventilation
- •Patient with a laryngeal stridor indicative of upper airway stenosis
- •Patient requiring an intubation by nasal route
- •Glasgow score < 12
- •BMI > 35
- •Pregnant or lactating women
- •Documented history of cognitive or psychiatric disorders
- •Difficult follow-up
结局指标
主要结局
The rate of BFI meeting quality requirements: the procedure must be successful on the one hand (≤ 2 attempts and duration < 180 sec); and well tolerated on the other hand (Fahey score < 2).
时间窗: 180 sec after the beginning of the intubation
次要结局
- Number of well-tolerated BFI procedures(At the end of the intubation)
- Duration of the intubation procedure among patients with a successful BFI (≤ 2 attempts and duration < 180 sec)(At the end of the intubation)
- Frequency and type of difficulties met by the operator(At the end of the intubation)
- Frequency and type of adverse events experienced by the patient(At the end of the intubation)
- Patient's perception of the intubation procedure(In the recovery room and 7 days after the intubation)