A Comparison Between C-MAC Video Laryngoscope an VS-CMAC Rigid Fiberoptic Stylet for Awake Endoscopic Intubation in Severe Predicted Difficult Airways: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- the success rate of the rigid fiberoptic stylet to perform tracheal intubation in patients with anticipated difficult airways
研究概览
简要总结
An Anticipated difficult tracheal intubation is recommended to be managed performing the so called "Awake tracheal endoscopic intubation" (ATI) with the maintenance of patient's spontaneous breathing after an adequate sedation and topical anesthesia of upper airways, providing supplemental oxygen.
Initially only flexible bronchoscope was considered the device of choice (the gold standard) for ATI but in the last decade videolaryngoscopes with hyper-angulated blade have been demonstrated to be an efficacy technique.
Most recently, endoscopic rigid stylets such as Bonfils (Carl Storz™) and Sensacope (Acoutronic™) have been proposed as alternative techniques for ATI in the event of expected difficult tracheal intubation.
However, to date, no comparison studies have been carried out between these two kind of devices, alternative to flexible fiberscope, for ATI.
This is a clinical prospective randomized-controlled trial of non inferiority. The aim of this study is to compare the intubation success rate between two different devices (C-MAC Video Laryngoscope and VS-CMAC fiberoptic stylet) in patients with severe predicted difficult airways scheduled for elective surgery.
The primary endpoint is the comparison of success rate for the tracheal intubation, demonstrating the non inferiority of videostylet efficacy compared to the most consolidated technique based on videolaryngoscope.
详细描述
This is a clinical prospective randomized-controlled trial of non inferiority, set in the operating theatre of a terziary university hospital in Ancona (Ospedali Riuniti Ancona).
The aim of this study is to compare the intubation success rate, defined as correct positioning of the tracheal tube inside the trachea, between Videostylet (VS-Carl Storz™) and videolaryngoscope with hyperangulated blade (C-MAC - Carl Storz™) in patients with severe predicted difficult airways scheduled for elective surgery.
All patients enrolled in the study, examined in the pre-operative visit, will be asked for informed consent and will undergo the same anesthetic protocol consisting in upper airways topicalization with Lidocaine and in smooth/moderate sedation (targeted on Ramsay sedation scale ≦ 3) by i.v. administration of midazolam 0,03 mg/kg and Fentanyl 100 mcg.
On arrival in the operating room, nasal oxygen (5 L/min) and routine monitoring of vital signs will be applied to all patients.
Heart rate and blood pressure will be recorded at the beginning of the procedure and every 3 minutes until the intubation will be performed, while arterial oxygen saturation is continuously recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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
- •Schedule for elective surgery
- •Detection of one or more of the following anthropometric criteria predictive of difficult intubation at the preoperative visit:
- •Limitation of Cervical spine movements (traumatic or surgical arthrodesis)
- •Mallampati score = 4
- •Thyromental distance < 6 cm
- •Interincisor distance < 3 cm
- •Suspected difficult ventilation via face mask
- •Previous history of difficult or failed intubation
排除标准
- •age <18 years
- •refusal of the patient
- •urgent-emergency surgery
- •patient's respiratory failure
结局指标
主要结局
the success rate of the rigid fiberoptic stylet to perform tracheal intubation in patients with anticipated difficult airways
时间窗: up to a maximum of 3 attempts and up to 3 minutes from device insertion for each attempt (max 9 minutes)
The primary endopoint is the comparison of success rate for the tracheal intubation in patients with anticipated difficult airways, demonstrating the non inferiority of videostylet efficacy compare to the most consolidated technique based on videolaryngoscope. success rate of the procedure defined as correct positioning of the tracheal tube in the trachea confirmed both endoscopically and through the capnographic curve EtCO2
次要结局
- Numbers of intubation attempts(up to a maximum of 3 attempts and up to 3 minutes from device insertion for each attempt (max 9 minutes))
- The degree of patient's tolerability of the procedure (with a special Analogue Numerical Scale)(up to 12 hours from the beginning of the procedure (from starting of awake intubation to complete recovering from general anaesthesia))
- The degree of subjective difficulty experienced by the operator(up to 15 minutes (from device insertion into the patient's mouth until the ETT will be positioned into the trachea))
- average time of intubation procedure expressed in seconds(up to 15 minutes)
- Development of any complications(up to 12 hours measured from the insertion of the device)
研究者
Abele Donati, MD
Director of the Clinic of Anaesthesia and Intensive Care, Principal Investigator, Clinical Professor
Università Politecnica delle Marche