The efficacy of Video-Assisted Fibreoptic Intubation compared to bougie-directed tracheal intubation in adult patients undergoing video laryngoscopy for elective surgeries: a single-blinded randomized controlled trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Time taken for successful intubation
研究概览
简要总结
During general anaesthesia for surgical procedures, patient’s breathing will be maintained by fixing an endotracheal tube inside the airway, which will be visualized using a laryngoscope. Video laryngoscope is one such instrument used for intubating a difficult airway. Various adjuncts can be used as a guide to locate the trachea like bougies and stylets. However, these adjuncts have the disadvantage of limited mobility and flexibility. Video-assisted Fibreoptic Intubation (VAFI) is a newer technique with combined use of fibreoptic scope and video laryngoscope. Not much research is available on comparison these methods in Indian population. This study compares the efficacy of VAFI compared to bougie guided endotracheal intubation using video laryngoscopy.
All patients undergoing general anaesthesia will be screened using inclusion criteria like age>18 years, ASA PS 1-II, and normal BMI. Older patients, emergency surgeries, critically ill and pregnant patients will be excluded from the study. Participants will be blinded and divided into 2 groups. After written informed consent, standard institutional protocol for general anaesthesia will be followed. Intubation will be done using video laryngoscopy with VAFI or bougie as adjunct depending on the assigned group. Efficacy of the adjuncts will be compared using time taken to intubate, success at first attempt, number of attempts at intubation, evidence of airway injury and hemodynamic changes after the procedure.
Data will be collected during the study period of 18 months. Following this, data analysis will be done to identify the superior method in terms of shorter intubation time, higher first attempt success rates, lesser number of attempts, and lesser incidence of airway injury and hemodynamic variability. This study would help in choosing a better guide for intubation which could be extrapolated for use in difficult airways. Limitations of this study include performer bias and need for assistant during the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients undergoing elective surgery under general anaesthesia ASA PS I and II BMI 18 – 30 kg/m2.
排除标准
- 未提供
结局指标
主要结局
Time taken for successful intubation
时间窗: Time from insertion of video laryngoscope blade into the mouth till tube cuff insufflation
次要结局
- First attempt tracheal intubation success or failure(First attempt success or failure will be assessed at the time of insertion of VAFI or bougie into the trachea for the first time.)
- Number of attempts(Number of attempts will be measured after successful intubation.)
- Airway injury(One hour & twenty four hours postoperatively)
- Hemodynamic changes(At the time of guide insertion, 1 minutes & 3 minutes after insertion)
研究者
Kalaranjani K
Sri Manakula Vinayagar Medical College and Hospital
