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CTRI Number  CTRI/2022/08/044684 [Registered on: 05/08/2022] Trial Registered Prospectively
Last Modified On: 13/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of efficacy of three types of laryngoscopes in adult patients posted for surgery 
Scientific Title of Study   A prospective randomised study to compare the efficacy of C-Mac Videolaryngoscope, VL3R videolaryngoscope and Macintosh laryngoscope as intubating aids in adult patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Akshaya Devi R 
Designation  Junior Resident 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University

Aligarh
UTTAR PRADESH
202002
India 
Phone  9962978297  
Fax    
Email  akshayar95@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Qazi Ehsan Ali 
Designation  Professor  
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University

Aligarh
UTTAR PRADESH
202002
India 
Phone  7417701769  
Fax    
Email  qaziehsanali@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Qazi Ehsan Ali 
Designation  Professor  
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, Aligarh Muslim University

Aligarh
UTTAR PRADESH
202002
India 
Phone  7417701769  
Fax    
Email  qaziehsanali@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, AMU, Aligarh 
 
Primary Sponsor  
Name  Department of Anaesthesiology and Critical Care Jawaharlal Nehru Medical College AMU Aligarh 
Address  Department of Anaesthesiology and Critical Care, Jawaharlal Nehru Medical College, AMU, Aligarh 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Akshaya Devi R  Jawaharlal Nehru Medical College, Aligarh Muslim University  Department of Anaesthesiology and Critical Care, SOT
Aligarh
UTTAR PRADESH 
9962978297

akshayar95@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K928||Other specified diseases of the digestive system,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Intubation   Intubation using C Mac videolaryngoscope 
Comparator Agent  Intubation   Intubation using VL3R videolaryngoscope 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  ASA Grade I &II patients.
Age between 20-70 years
Weight between 40-70 kg 
Patients of both sexes
Patients planned for elective surgery
MP Grades I and II
 
 
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 heartburn) 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   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To compare the number of attempts required for successful intubation.
 
2 years  
 
Secondary Outcome  
Outcome  TimePoints 
To grade the ease of tracheal intubation using these devices.
To compare the laryngoscopy and intubation time using the three intubating devices.
To compare the number of adjustment maneuvers required for successful intubation each device.
To look for any complications like trauma and sore throat during laryngoscopy and intubation.
 
2 years 
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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 3 
Date of First Enrollment (India)   16/08/2022 
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="2"
Months="0"
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   A PROSPECTIVE RANDOMIZED STUDY TO COMPARE THE EFFICACY OF C-MAC VIDEO LARYNGOSCOPE, VL3R VIDEO LARYNGOSCOPE AND MACINTOSH LARYNGOSCOPE AS INTUBATING AIDS IN ADULT PATIENTS

Airway management is quite essential in cardiopulmonary resuscitation, anaesthesia, emergency medicine, intensive care and first aid, as it saves lives. Laryngoscopy may be performed to facilitate tracheal intubation during general anaesthesia or cardiopulmonary resuscitation or for surgical procedures on the larynx or other parts of the upper tracheobronchial tree. Direct laryngoscopy (DL) does not always allow optimal viewing of the glottis, especially in those patients with anatomical characteristics which can make tracheal intubation difficult1. The American Society of Anesthesiologists’ closed claim study showed that difficult intubation or esophageal intubation is the cause of the approximately 35% of life-threatening respiratory events, including death and permanent brain damage2. Thus managing a difficult airway is one of the major problems that an anaesthesiologist can encounter in clinical practice.

     These issues have stimulated the development of multiple novel laryngoscopes, each of which aims to improve the laryngeal view, especially in cases of anticipated/unanticipated difficult airway3. The greater effectiveness of video-laryngoscopes associated with multi-person visualization could enhance overall patient safety during airway management4. Although they offer several advantages, including better view of glottis entrance and intubation conditions, a good laryngeal view does not guarantee easy or successful tracheal tube insertion5


     We therefore aim to compare the number of attempts required for successful intubation using C – MAC video laryngoscope, VL3R video laryngoscope and Macintosh laryngoscopes and to arrive at a conclusion and to grade them based on the various characteristics.


 
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