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CTRI Number  CTRI/2018/03/012378 [Registered on: 06/03/2018] Trial Registered Retrospectively
Last Modified On: 27/02/2018
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 Prospective Randomized Study To Compare King Vision Video Laryngoscope And McGrath Video Laryngoscope In Adults Patients Undergoing Laparoscopic Cholecystectomy 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mohammad Ahmad Khan 
Designation  Junior Resident 
Affiliation  JNMCH AMU ALIGARH 
Address  C12 Second Floor Rifa Palace Infront Of Green Crescent School Medical Road Aligarh AMU Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  9457665723  
Fax    
Email  ahmadkhn43@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Syed Hussain Amir 
Designation  Assistant Professor 
Affiliation  JNMCH AMU ALIGARH 
Address  Department of Anaesthesia 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  Mohammad Ahmad Khan 
Designation  Junior Resident 
Affiliation  JNMCH AMU ALIGARH 
Address  C12 Second Floor Rifa Palace Infront Of Green Crescent School Medical Road Aligarh AMU Aligarh

Aligarh
UTTAR PRADESH
202002
India 
Phone  9457665723  
Fax    
Email  ahmadkhn43@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 
Mohammad Ahmad Khan  Jawaharlal Nehru Medical College AMU Aligarh  Department of Anaesthesiology and Critical Care Jawaharlal Nehru Medical College Aligarh Muslim University
Aligarh
UTTAR PRADESH 
9457665723

ahmadkhn43@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ASA Physical Status I and II,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  King Vision Video laryngoscope and McGrath Video laryngoscope  Intubation time comparison 
Comparator Agent  McGrath Video laryngoscope  Intubation time comparison 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA Grade I and II
Weight between 40-70 Kg
Patients planned for Elective Laparoscopic Cholecystectomy 
 
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.
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 laryngoscopy & intubation time using the two devices.
To compare the glottic view using POGO (percentage of glottic opening) score.
To compare the hemodynamic response i.e., heart rate and mean arterial B.P. after laryngoscopy and intubation.
To compare the success of laryngoscopy & intubation in all classes of Mallampati grading.
 
Two years from start of study 
 
Secondary Outcome  
Outcome  TimePoints 
To grade the ease of tracheal intubation using these devices.
To compare the number of adjustment maneuvers required for successful intubation.
To look for post operative complications if any. 
2 yrs 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" 
Phase of Trial   N/A 
Date of First Enrollment (India)   22/03/2016 
Date of Study Completion (India) 10/12/2017 
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  

This study entitled “A Prospective Randomized Study To Compare  King Vision Video Laryngoscope And McGrath Video Laryngoscope In Adult Patients Undergoing Laparoscopic Cholecystectomy” was performed to compare the two different laryngoscopes.

60 ASA physical status I and II of either sex (20-60 yrs. of age) undergoing general anaesthesia for elective laparoscopic cholecystectomy surgery were included in the study. Patients with all MP class were included. After obtaining approval from Board of studies Department of Anaesthesiology and Institutional ethical committee, patients were randomly divided into two groups. Patients of KV Group [N=30] were intubated using King Vision video laryngoscope and patients of MV Group [N=30] were intubated using McGrath video laryngoscope. Blinding of the attending laryngoscopists was not possible as the two laryngoscopes were markedly different.

All patients in the both groups were monitored using  all standard monitors; female patients were intubated with 7.0 mm PVC ETT (endotracheal tube) whereas male patients were intubated with 8.0 mm PVC ETT

The King Vision VLs and McGrath VLs were compared with each other with respect to laryngoscopy and intubation time, changes in heart rate and blood pressure after intubation at different interval of time, number of attempts for successful intubation, number of adjustment maneuvers, ease of tracheal intubation and post extubation complications.

Of all the patients who were intubated; 93.33% of the patients were intubated in single attempt with King Vision VLs as compared to 70% with McGrath VLs. However second attempts intubation rate was 100% both in King Vision VLs and McGrath VLs. Among the two instruments none had taken more than two attempts for successful intubation. 

The King Vision VLs did required less adjustment maneuvers as compared to McGrath VLs. 10% and 46.66% patients required more than two adjustment maneuvers in King Vision VLs and McGrath VLs respectively.

The incidence of ease of intubation grade 1 with King Vision VLs and McGrath VLs was 90% and 63.33% respectively. However 10% and 36.66% patients had grade II ease of intubation in King Vision VLs and McGrath VLs respectively. Among the two instrument none had shown a failed intubation.

The mean intubation time was 12.56 second and 22.2 seconds in King Vision VLs and McGrath VLs respectively. McGrath VLs required more time than King Vision VLs to intubate the patients.

In both groups; there was a significant rise in heart rate from pre induction value to immediate post intubation, 3 and 5 minute of post intubation but came down near to pre induction value within 10 minutes of intubation. In inter group comparison between two groups at a time, variation in heart rate did show statistically significant rise with McGrath VLs as compared to King Vision VLs during 3 min post intubation.

Both groups showed significant change in MABP at post intubation period, although comparatively lesser in KV group. Rise in MABP was statistically significant at immediate post intubation and 3 minute post intubation time.

The incidence of complications like sore throat, blood staining on ETT and hoarseness after extubation was less in KV group as compared to MV group.

 
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