NCT04334616

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

  1. 1.Sore Throat: A sore throat is pain, scratchiness or irritation of the throat usually from irritation or inflammation of the throat (pharynx)(11).
  2. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 19, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 2, 2018

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

March 28, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 6, 2020

Completed
Last Updated

April 6, 2020

Status Verified

April 1, 2020

Enrollment Period

10 months

First QC Date

March 28, 2020

Last Update Submit

April 2, 2020

Conditions

Sore Throat

Keywords

Video LaryngoscopeMacintosh LaryngocsopeVDLKarl Storz Video LaryngoscopeIntubationPost Operative Sore ThroatAnaesthesia Trainee

Outcome Measures

Primary Outcomes (1)

  • Post Operative Sore Throat

    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.

    24 hours

Study Arms (2)

Conventional Laryngocope

ACTIVE COMPARATOR

Patients in this arm will be intubated with conventional Macintosh laryngoscope

Device: Macintosh Conventional Laryngocope

Video Laryngocope

ACTIVE COMPARATOR

Patient in this arm will be intubated with Karl Storz Video Laryngoscope

Device: Video Laryngocope

Interventions

Video LaryngocopeDEVICE

VDL used for VDL arm

Video Laryngocope
Macintosh Conventional LaryngocopeDEVICE

Used for Conventional laryngocope arm

Also known as: Conventional Laryngocope
Conventional Laryngocope

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aga Khan University

Karachi, Sindh, 74800, Pakistan

Location

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsPharyngeal DiseasesStomatognathic DiseasesRespiratory Tract DiseasesOtorhinolaryngologic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
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.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Randomized Control Trial (Observer Blinded)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Investigator

Study Record Dates

First Submitted

March 28, 2020

First Posted

April 6, 2020

Study Start

June 19, 2017

Primary Completion

April 24, 2018

Study Completion

July 2, 2018

Last Updated

April 6, 2020

Record last verified: 2020-04

Locations

PA(1)