| CTRI Number |
CTRI/2019/07/020427 [Registered on: 29/07/2019] Trial Registered Prospectively |
| Last Modified On: |
23/09/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between linscope videolaryngoscope and king vision videolaryngoscope |
|
Scientific Title of Study
|
A comparative evaluation between linscope videolaryngoscope and king vision videolaryngoscope in patients undergoing tracheal intubation under general anaesthesia - a randomized control study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mohd Luqman |
| Designation |
Resident Doctor |
| Affiliation |
JNMCH |
| Address |
H.No 4/24
Firdaus Nagar B
Qila road,Near university horse rididng field
Departmenet of Anaesthesia & Criticalcare.
AMU,Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9258176105 |
| Fax |
|
| Email |
mohdluqman34@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syed Moied Ahmed |
| Designation |
PROFESSOR |
| Affiliation |
|
| Address |
Department of Anaesthesia and Critical care
JNMCH
AMU
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897454739 |
| Fax |
|
| Email |
sma99@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Syed Moied Ahmed |
| Designation |
PROFESSOR |
| Affiliation |
|
| Address |
Department of Anaesthesia & Critical care
JNMCH
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897454739 |
| Fax |
|
| Email |
sma99@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anesthesiology and Critical Care, JNMCH,AMU,Aligarh. |
|
|
Primary Sponsor
|
| Name |
Department of Anesthesiology and Critical Care |
| Address |
JNMCH, AMU |
| Type of Sponsor |
Government medical college |
|
|
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 |
| MOHD LUQMAN |
Jawahar lal Nehru Medical College and Hospital,Aligarh Muslim University,Aligarh |
Department of
Anesthesiology and
Critical care,Jawahar lal
Nehru Medical College
,Aligarh Muslim
University,Aligarh.
Aligarh
UTTAR PRADESH
Aligarh
UTTAR PRADESH |
9258176105
MOHDLUQMAN34@GMAIL.COM |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R688||Other general symptoms and signs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
King Vision videolaryngoscope |
It is a video laryngoscope for intubating under vision. |
| Intervention |
Linscope Video laryngoscope |
It is a video laryngoscope used for intubating patients under vision. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA Grade I and II patients
Age between 20-65 years
Weight between 40-75kg
Patients of both sexes
Patients planned for elective surgery
All classes of MP grades
|
|
| ExclusionCriteria |
| Details |
Previous history of multiple /failed intubation
Predicted difficult laryngoscopy
Any pathology of the oral cavity that may obstruct the insertion of
device
Mouth opening less than 2.5cm
Potentially full stomach patients (trauma,morbid
obesity,pregnancy,history of gastric regurgitation and heart burn)and
at risk of oesophageal reflux (hiatus hernia |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Intubation time |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Ease of tracheal intubation Glottic view using
Cormack and Lehane Grading
Adjustment maneuvers required for successful
intubation
Changes in heart rate and mean arterial blood
pressure during laryngoscopy and intubation
Any trauma during laryngoscopy and intubation |
1 year |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 1 |
|
Date of First Enrollment (India)
|
29/07/2019 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A comparative evaluation between linscope videolaryngoscope and kingsvision videolaryngoscope inpatients undergoing tracheal intubation under general anaesthesia a randomized control study. Mohd Luqman***, Syed Moied Ahmed** Department of Anesthesiology and Critical Care JNMCH AMU Aligarh ***Presenting Author,**Professor,* INTRODUCTION Airway management is of supreme importance in any clinical situation including cardiopulmonary resuscitation, anesthesia ,emergency medicine,intensive care and first aid as it is one of the life saving measures described under the acronym ABCD.Managing a difficult airway has always been a challenging task for an Anesthesiologist,as at times it is life threatening. The curved laryngoscopic blade described by Macintosh in 1943 is the most popular device for tracheal intubation till date but its use is a difficult skill to acquire and even the most experienced Anesthesiologist may encounter difficulties in its use.So alternative techniques have been developed to assist intubation in such cases of difficult direct laryngoscopy.Video laryngoscopy is relatively recent development that improves the success of tracheal intubation. The purpose of the study is to compare the ease of intubation using Video laryngoscope(Linscope Video laryngoscope) and kingsvision in elective adult surgical patients. Materials and Methods Elective endotracheal intubation will be carried out by using linscope video laryngoscope, and kingsvision video laryngoscope in 30 patients in each group. Intubation time, ease of intubation.,number of adjustment maneuvers,glottic view using Cormack Lehane Grading,changes in heart rate and mean arterial blood pressure during laryngoscopy and intubation ,any trauma during the same will be compared in 2 groups. RESULT Study will be started after a few weeks.Above quoted parameters will be recorded and compared |