The Shikani Optical Stylet As An Alternative To Awake Fiberoptic Intubation In Patients At Risk Of Secondary Cervical Spine Injury - A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 主要终点
- Coughing and gagging
研究概览
简要总结
Background: Conventional intubation of the trachea and consequent prone positioning of anaesthetized patients with cervical spine instability may result in secondary neurological injury. Historically, the flexible fiber-optics used to be the chief choice for patients presenting with cervical spine instability surgery either with normal, predicted difficult airway, or even unanticipated difficult airway. Recently, the rigid optical stylets have shown promise in assisting difficult intubations.
Purpose: The aim of the present study was to compare the efficacy of Shikani optical stylet (SOS) with the flexible fiberscope for awake intubation in patients with cervical spine instability.
Methods: Sixty adult patients with a neurosurgical diagnosis of cervical instability or at risk of secondary cervical injury, who were planned for awake intubation and self-positioning prone, were registered in this study and were randomly categorized into two equal groups (thirty patients each), a fiberoptic group and a SOS group, then assessment of coughing and gagging during and after intubation, time to intubation, number of attempts for successful intubation, haemodynamic parameters, careful examination of the oropharynx to determine any lip or mucosal trauma, and eventually the motor function by the ability to move arms and legs were assessed after tracheal intubation and after positioning prone.
详细描述
Aim of the work:
The aim of this study was to compare the efficacy of shikani optical stylet with the flexible fiberoptic bronchoscope for awake intubation in patients with cervical spine instability.
Patients and Methods:
This prospective, randomized study was approved by the local ethical committee of Alexandria main university hospital. Written informed consent was obtained from all the participants. Sixty patients aged 18-65 year with American Society of Anaesthesiologists physical status I-III with a neurosurgical diagnosis of cervical instability or at risk of secondary cervical injury, who were scheduled for awake intubation and self-positioning prone for elective neurological intervention, were enrolled in this study. Patients with increased risk of pulmonary aspiration, requirement for rapid sequence induction or associated head injury precluding adequate clinical neurological examination were excluded from the study. All patients received rigid neck collar. Data collected from each patient included demographic data, level of cervical spine pathology and the neurological status.
An assistant who wasn't concerned within this study got numbered opaque pre-sealed envelopes containing the randomised group allocations after every patient was joined into the study. Patients were randomly assigned into either a fiberoptic group (30) or a Shikani group (30) utilizing a sealed-envelope technique.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •American Society of Anaesthesiologists physical status I-III with a neurosurgical diagnosis of cervical instability or at risk of secondary cervical injury, who were scheduled for awake intubation and self-positioning prone for elective neurological intervention
排除标准
- •Patients with increased risk of pulmonary aspiration, requirement for rapid sequence induction or associated head injury precluding adequate clinical neurological examination were excluded from the study.
结局指标
主要结局
Coughing and gagging
时间窗: during and after intubation
using a scale of 1 to 4: (1= none; 2 \< 3 times (slight coughing and gagging comparable to "clearing ones throat"); 3 \> 2 times (mild coughing or gagging lasting less than a minute); 4 = persistent coughing or gagging\]
Time to intubation
时间窗: the interval from the start of intubation to the completion of intubation
Measure the time in minutes from the start of intubation to the completion of intubation
Number of attempts for successful intubation
时间窗: During intubation
How many trials were taken till achieve the intubation
The changes in the haemodynamic parameters
时间窗: Pre-induction, pre-intubation and at 3 and 5 min after intubation
the haemodynamic parameters including: heart rate, systolic and diastolic blood pressures during the intubation process with readings taken pre-induction, pre-intubation and at 3 and 5 min after intubation.
次要结局
未报告次要终点
研究者
Rabab Sber Saleh Mahrous
principal investigator
University of Alexandria