| CTRI Number |
CTRI/2021/08/035847 [Registered on: 23/08/2021] Trial Registered Prospectively |
| Last Modified On: |
19/08/2021 |
| 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 intubating devices vLarynx Video Laryngoscope and Airtraq optical laryngoscope. |
|
Scientific Title of Study
|
A Prospective randomized study to compare vLarynx video laryngoscope and Airtraq in adult patients undergoing elective general surgery. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Md Shahab Saquib |
| Designation |
Junior Resident |
| Affiliation |
Jawaharlal Nehru Medical College, AMU, Aligarh |
| Address |
Department of anaesthesiology and critical care, JNMCH, AMU, Aligarh, India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9045929995 |
| Fax |
|
| Email |
shahab1395amu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syed Hussain Amir |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College, AMU, Aligarh |
| Address |
Department of Anaesthesiology and critical care,JNMCH, AMU, Aligarh, India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897559183 |
| Fax |
|
| Email |
hussainamir77@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Syed Hussain Amir |
| Designation |
Associate Professor |
| Affiliation |
Jawaharlal Nehru Medical College, AMU, Aligarh |
| Address |
Department of Anaesthesiology and critical care,JNMCH, AMU, Aligarh, India
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897559183 |
| Fax |
|
| Email |
hussainamir77@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care, JNMCH, AMU |
|
|
Primary Sponsor
|
| Name |
Department Of Anaesthesiology and Critical Care JNMCH AMU |
| Address |
Department of Anaesthesiology and Critical Care, JNMCH, AMU, Aligarh |
| Type of Sponsor |
Government medical college |
|
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Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Md Shahab Saquib |
Jawaharlal Nehru Medical College and Hospital, AMU |
OT Complex, Department of Anesthesiology,JNMCH, AMU
Aligarh
UTTAR PRADESH |
9045929995
shahab1395amu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Airtraq |
Optical channelled laryngoscope used for intubation
therapy duration depends on airway difficulty and MP grading. |
| Intervention |
vLarynx video laryngoscope |
video laryngoscope used for intubation.
therapy duration depends on airway difficulty and MP grading. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA grade 1 and 2
Age between 20 and 60 years
Weight between 41 and 80 kg
Gender - male and female
Patients planned for elective surgeries |
|
| ExclusionCriteria |
| Details |
Cervical spine injury
Head and Neck Surgery
Valvular Heart Disease
CAD / uncontrolled hypertension
Presence of raised intracranial pressure
Mouth opening less than 2.5 cm
Any pathology of oral cavity that will obstruct the insertion of device |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the number of attempts and time taken using the two devices for intubation. |
8 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
to compare the glottic view using POGO (percentage of glottic opening) score
Ease of tracheal intubation using these devices
to compare the number of adjustment maneuvers required for successful intubation.
to compare hemodynamic response after laryngoscopy and intubation.
to look for post operative complications if any.
to compare success of laryngoscopy and intubation in all classes of Mallampati grading. |
8 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
25/08/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="8"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
ABSTRACT
A prospective randomized study to compare vLarynx video laryngoscope and Airtraq in adult patients undergoing elective general surgery.
Md Shahab Saquib***, Syed Hussain Amir**, Qazi Ehsan Ali*
Department of Anaesthesiology and Critical Care, JNMCH, AMU, Aligarh
***Presenting author **Supervisor *Co-Supervisor
INTRODUCTION
Difficulty in tracheal intubation is most important factor which is related to serious airway complications during general anaesthesia. So, managing difficult airway remains challenging task for anesthesiologist. Securing an airway by tracheal intubation using Macintosh laryngoscope is considered gold standard in airway management. Tracheal intubation using direct laryngoscope requires alignment of oro-pharyngeal-laryngeal axis for visualization of glottic opening and is a technical skill which is difficult to acquire and maintain in all conditions.
Video laryngoscopes have become widely popular in recent years. These are relatively new devices available for tracheal intubation which provide a view of glottic opening from video camera or video chip positioned close to the tip of laryngoscope blade. It facilitates easy visualization of glottic opening without the need for aligning oro-pharyngeal-laryngeal axis.
The aim of this study is to compare the efficiency of vLarynx video laryngoscope with Airtraq laryngoscope as control while intubating patients.
Materials and Methods
The study will include 60 patients undergoing elective general surgery under general anesthesia requiring tracheal intubation. 30 patients will be included in each group.
Primary objective - to compare the number of attempts and time taken using two devices for intubation.
Secondary objective - to compare glottic view, to grade the ease of tracheal intubation, to compare the number of adjustment maneuvers, to compare hemodynamic response after laryngoscopy and intubation, to look for post operative complications if any, to compare the success of laryngoscopy and intubation in all classes of Mallampati grading.
RESULT
Above quoted parameters will be recorded and compared in this study.
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