| CTRI Number |
CTRI/2018/04/013458 [Registered on: 24/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
23/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison between two video laryngoscope |
|
Scientific Title of Study
|
A Comparative Evaluation Of King Vision Videolaryngoscope and Airtraq Optical Laryngoscope as Intubating Device in Adult Patients Undergoing Elective General Surgery |
| Trial Acronym |
Airway |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Amrin Bader |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Nehru Medical College AMU Aligarh |
| Address |
Department of Anaesthesiology and critical care
Jawaharlal Nehru Medical College
AMU,Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9997759190 |
| Fax |
|
| Email |
amrinbadar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syed Hussain Amir |
| Designation |
Assistant Professor |
| Affiliation |
Jawaharlal Nehru Medical College AMU Aligarh |
| Address |
Department of Anaesthesiology and Critical Care
Jawaharlal Nehru Medical College
AMU,Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8218496722 |
| Fax |
|
| Email |
hussainamir77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Amrin Bader |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Nehru Medical College AMU Aligarh |
| Address |
Department of Anaesthesiology and critical care
Jawaharlal Nehru Medical College
AMU,Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9997759190 |
| Fax |
|
| Email |
amrinbadar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Nehru Medical College AMU, Aligarh |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology |
| Address |
Department of Anaesthesiology and Critical Care Jawaharlal Nehru Medical College Aligarh Muslim University, Aligarh |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Qazi Ehsan Ali |
Professor Department of Anaesthesiology and Critical Care Jawaharlal Nehru Medical College Aligarh Muslim University, Aligarh |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Amrin Bader |
Jawaharlal Nehru Medical College AMU Aligarh |
Department of Anaesthesiology and Critical Care Jawaharlal Nehru Medical College Aligarh Muslim University
Aligarh
UTTAR PRADESH
Aligarh
UTTAR PRADESH |
9997759190
amrinbadar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Faculty of Medicine, AMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
ASA Physical Status I and II , |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Airtraq optical video laryngoscope |
Intubation time comparison and hemodynamics |
| Intervention |
King Vision Video laryngoscope and Airtraq Video laryngoscope |
Intubation Time comparison and Hemodynamics |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I and II
Weight between 45-70 Kg
Patients planned for Elective Surgery |
|
| ExclusionCriteria |
| Details |
Previous history of multiple/ failed intubation.
Head and neck surgery.
Valvular heart disease.
CAD / Uncontrolled hypertension.
Presence of raised intracranial pressure.
Cervical spine injury.
Predicted difficult laryngoscopy except for all class of MP Grades
Any pathology of the oral cavity that will obstruct the insertion of device.
Mouth opening <2.5cm.
Potentially full stomach patients (trauma, morbid obesity, pregnancy, history of gastric regurgitation and heart burn) and at risk of esophageal reflux (hiatus hernia). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To compare the intubation time using the two devices.
|
2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare success rate at first attempt
To compare the glottic view using Cormack and Lehane Grading.
To compare the hemodynamic response i.e., heart rate and mean arterial B.P. after laryngoscopy and intubation.
To Grade the ease of tracheal intubation using these devices.
To compare the number of adjustment maneuvers required for successful intubation.
To look for complications like post-extubation blood staining on endotracheal tube and incidence of postoperative sore throat |
2yrs |
|
|
Target Sample Size
|
Total Sample Size="54"
Sample Size from India="54"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2015 |
| Date of Study Completion (India) |
29/10/2016 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The study entitled "A Comparative Evaluation Of King Vision Videolaryngoscope And Airtraq Optical Laryngoscope As Intubating Device In Adult Patients Undergoing Elective General Surgery" was conducted on 60 ASA I and II patients of either sex aged between 20-60 years and in the weight range of 45 to 70 kg after obtaining informed consent. We compared the two video laryngoscope in terms of intubation time and hemodynamic response i.e., heart rate and Mean arterial Blood Pressure (MAP) after laryngoscopy and intubation. This was a single blinded Randomised parallel comparative study evaluating the characteristics of the two devices and its usefulness in clinical practice. Results favours that King Vision video laryngoscope better than Airtraq optical video laryngoscope |