Post Operative Sore Throat: Comparison of Macintosh Laryngoscope Versus Video Laryngoscope in Patients Intubated by Anaesthesia Trainee
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Aga Khan University
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- Post Operative Sore Throat
Study Overview
Brief Summary
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.
Detailed Description
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)
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Masking Description
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.
Eligibility Criteria
- Ages
- 20 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Conventional Laryngocope
Patients in this arm will be intubated with conventional Macintosh laryngoscope
Intervention: Macintosh Conventional Laryngocope (Device)
Video Laryngocope
Patient in this arm will be intubated with Karl Storz Video Laryngoscope
Intervention: Video Laryngocope (Device)
Outcomes
Primary Outcomes
Post Operative Sore Throat
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Amin Ahmed Kapadia
Investigator
Aga Khan University