Efficacy of Bonfils Fiberoptic Stylet for Tracheal Intubation With Double Lumen Tube After Failure of Direct Laryngoscopy. A Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- the efficacy of Bonfils fiberoptic stylet to perform tracheal intubation with double lumen tube after failure of standard laryngoscopy
研究概览
简要总结
The aim of this prospective observational study is to evaluate the efficacy of Bonfils fiberoptic stylet to perform tracheal intubation with double lumen tube after failure of standard laryngoscopy in 30 adults patients scheduled for elective thoracic surgery, who require tracheal intubation with double lumen tube for One Lung Ventilation under general anesthesia in a teaching hospital operating theatre at Ospedali Riuniti Ancona (Italy).
详细描述
This is a prospective, observational study, approved by Marche's Regional Ethics Committee (CERM), Ancona, ITA on the 07 February 2019. The study is conformed to the Declaration of Helsinki and Good Clinical Practice guidelines, an informed written consent will be obtained at recruitment.
The aim of this study is to evaluate the efficacy of Bonfils fiberoptic stylet to perform tracheal intubation with double lumen tube (DLT) after failure of standard laryngoscopy in 30 adult patients (patients 18 years of age) scheduled for elective thoracic surgery, who require tracheal intubation with (DLT) for One Lung Ventilation (OLV) under general anesthesia. The study will be performed in a teaching hospital operating theatre at AOU Ospedali Riuniti Ancona (Italy).
Pre-operative evaluation will be done before surgery, demographic variables will be collected and the clinical screening tests to predict a difficult airway will be performed.
On the day of the intervention, patients will be subjected to standard monitoring of vital signs (NIBP, FC, SpO2 and ECG) and, after induction of general anesthesia and adequate pre-oxygenation (3-minutes with facial mask ventilation), a direct laryngoscopy with Macintosh blade will be performed to insert a DLT. The Cormack-Lehane grade view will be registered after optimization of the intubation attempt by improving the "sniffing position" and the external manipulation of the larynx (BURP maneuver). In case of declaration of intubation failure, it will be used Bonfils fiberscope for the DLT insertion.
A maximum duration of intubation attempt is not established, but a decrease in SpO2 below 90% will be considered as a criterion for abandoning the procedure and the patient will be re-oxygenated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •adults (age≥18 years)
- •tracheal intubation with double lumen tube (DLT) for One Lung Ventilation (OLV) required for elective thoracic surgery under general anaesthesia
排除标准
- •patients undergoing emergency thoracic surgery
- •patients with predictive criteria of difficult ventilation scheduled for "awake endoscopic intubation"
- •patients with anatomical features that contraindicate direct laryngoscopy
结局指标
主要结局
the efficacy of Bonfils fiberoptic stylet to perform tracheal intubation with double lumen tube after failure of standard laryngoscopy
时间窗: up to 2 minutes from device insertion
the success rate of the procedure defined by the correct position of the double-lumen tube in the bronchial lumen verified by a flexible fiberscope
次要结局
- Time to intubation,(up to 2 minutes from device insertion)
- Any complications occurred(up to 12 hours measured from the insertion of the device)
- Number of intubation attempts(up to 15 minutes. The maximum number of attempts allowed will be 2 for the Macintosh laryngoscope and 2 for the Bonfils fiberscope, after which, in case of failure with the both devices, the patient will be awakened.)
研究者
Abele Donati, MD
Director
Università Politecnica delle Marche