Post Operative Sore Throat: Comparison of Macintosh Laryngoscope Versus Video Laryngoscope in Patients Intubated by Anaesthesia Trainee
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Post Operative Sore Throat
研究概览
简要总结
OBJECTIVES The objective of this study is to compare the frequency of POST in patients intubated by trainee anaesthetist using Video LaryngoscopeTM(VDL) versus Conventional Macintosh Laryngoscope (CL) at a tertiary care hospital in Karachi, Pakistan
OPERATIONAL DEFINITIONS
- Sore Throat: A sore throat is pain, scratchiness or irritation of the throat usually from irritation or inflammation of the throat (pharynx)(11).
The visual analogue scale (0-10) will be used to evaluate the severity of sore throat 2. Trainee Anesthetist: Anesthesia residents level I and II having experience of more than six months. They will have to achieve the initial competence of doing intubation under direct supervision and need to be familiar with conventional as well as VDL technique.
HYPOTHESIS:
NULL HYPOTHESIS: There is no difference in the frequency of POST in patients intubated by trainee anaesthetists using VDLTM versus conventional Macintosh laryngoscope.
ALTERNATE HYPOTHESIS: There is a difference in the frequency of POST in patients intubated by trainee anaesthetists using VDLTM versus conventional Macintosh laryngoscope.
详细描述
MATERIAL AND METHODS
SETTING: The study will be conducted at main Operating Room, Department of Anaesthesiology, Aga Khan University Hospital Karachi.
DURATION OF STUDY: This study will be conducted for a period of one year or till the completion of sample size after approval of synopsis by ERC and CPSP.
SAMPLE SIZE:
W.H.O software is used to calculate sample size (See Annexure 1) Frequency of POST in VDL group = 28% (7) Frequency of POST in CL Group =54% (7) Power of the test = 80% Type I error= 5% Sample size in each group =55 (Total sample size 110)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
After approval from Ethical Review Committee potential patients will be screened in the ward. After eligibility, the consent will be administered by the study investigators. If patient agree to participate and signed the consent, he/she will be enrolled in the study. Selected patients will be randomly allocated by a computer-generated number, either into conventional laryngoscopy (CL) group or video laryngoscopy (VDL) group through sealed envelopes.
入排标准
- 年龄范围
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All adult patient of age between 20-60 year
- •American society of Anesthesiologist grade I and II
- •Scheduled for elective laparoscopic cholecystectomy
- •Both male and female genders
排除标准
- •Anticipated difficult airway as assessed by limited mouth opening (< 2 finger breadth), Limited neck extension.
- •Obesity having BMI>30 kg/m2
- •Any anatomical air way abnormality like cancers of oropharngeal cavity, patient who got radiotherapy in head and neck region known to the primary investigator through patients history
- •Patient having history of GERD requiring rapid sequence induction with cricoid pressure
- •Duration of the surgery exceeding two and a half hours (150 minutes)
- •Patient not intubated within three laryngoscopy attempt
结局指标
主要结局
Post Operative Sore Throat
时间窗: 24 hours
Patient will be observed for postoperative sore throat post operatively by the primary investigator who is blinded to the group allocation. The visual analogue scale (0-10) will be used to evaluate the severity of sore throat. The definite measurement of POST will be taken at 24 hours.
次要结局
未报告次要终点
研究者
Amin Ahmed Kapadia
Investigator
Aga Khan University