FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/03/063575 [Registered on: 04/03/2024] Trial Registered Prospectively
Last Modified On: 04/03/2024
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 different methods of securing airway in patients undergoing surgery under general anaesthesia 
Scientific Title of Study   Comparison of airway management with I-gel,Cuffed Laryngeal Mask Airway and Cuffed Endotracheal Tube in patients undergoing surgery under general anaesthesia-A Randomized Clinical Trial 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  JYOLSNA M S 
Designation  Post Graduate Trainee 
Affiliation  Regional Institute of Medical Sciences, Imphal ,Manipur 
Address  Department of Anaesthesiology,Regional Institute of Medical Sciences

Imphal West
MANIPUR
795004
India 
Phone  6282579872  
Fax    
Email  msjyolsna@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr N Anita Devi 
Designation  Professor 
Affiliation  Regional Institute of Medical Sciences,Imphal 
Address  Department of Anaesthesiology,Regional Institute of Medical Sciences

Imphal West
MANIPUR
795004
India 
Phone  8787458045  
Fax    
Email  dranitadevin@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr N Anita Devi 
Designation  Professor 
Affiliation  Regional Institute of Medical Sciences,Imphal 
Address  Department of Anaesthesiology,Regional Institute of Medical Sciences

Imphal West
MANIPUR
795004
India 
Phone  8787458045  
Fax    
Email  dranitadevin@gmail.com  
 
Source of Monetary or Material Support  
Department of Anaesthesiology,Regional Institute of Medical Sciences ,Imphal,Manipur 
 
Primary Sponsor  
Name  Jyolsna M S 
Address  Regional Institute of Medical Sciences, Imphal ,Manipur 
Type of Sponsor  Other [Self,Post Graduate Trainee] 
 
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 
Dr Jyolsna M S  Regional Institute of Medical Sciences,Imphal West,Manipur  Elective Surgery Operation Theatre Complex (OT 1-8) ,Department of Anaesthesiology,Regional Institute of Medical Sciences
Imphal West
MANIPUR 
6282579872

msjyolsna@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research Ethics Board, Regional Institute of Medical Sciences,Imphal,Manipur  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  , (1) ICD-10 Condition: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Airway will be secured by Cuffed Endotracheal tube.  Study participants will be randomized into three groups,each group containing 50 groups each.Airway will be secured by Cuffed Endotracheal Tube in Group C.At baseline,Insertion time in seconds,ease of insertion and number of attempts required for Cuffed Endotracheal tube insertion will be noted. 
Intervention  Airway will be secured by Cuffed Laryngeal Mask Airway  Study participants will be randomized into three groups,each group containing 50 patients each.Airway will be secured by Cuffed Laryngeal Mask Airway in Group B.At baseline,Insertion time in seconds,ease of insertion and number of attempts required for cuffed Laryngeal Mask Airway insertion will be noted. 
Intervention  Airway will be secured by I-gel  Study participants will be randomized into three groups,each group containing 50 patients.Airway will be secured by I-gel in Group A.At baseline,Insertion time,ease of insertion and number of attempts required for I-gel insertion will be noted. 
Comparator Agent  Not Applicable  Not Applicable 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients aged between 18 to 60years
2.American Society of Anaesthesiologists status I and II
3.Patients undergoing elective surgical procedure under general anaesthesia of duration 60 to 90 minutes
4.Modified Mallampati Score I and II
5.Thyromental distance above 6.5 centimetre
 
 
ExclusionCriteria 
Details  1.Patients with recognised or threatened risk of gastroesophageal reflux
2.Obese patients with BMI more than 30
3.Pregnant women
4.Patients with co existing cardiac disease
5.Patients on antihypertensives
6.Patients undergoing procedures requiring head and neck manipulation
7.Chronic infection or diseases
8.Patients with history of motion sickness 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Compare I-gel,Cuffed Laryngeal Mask Airway and cuffed Endotracheal intubation with regards to the ease of insertion,insertion time and number of attempts  Outcome will be assessed after insertion of airway device at baseline. 
 
Secondary Outcome  
Outcome  TimePoints 
To compare the hemodynamic changes after insertion of the airway device & associated side effects if any.  Hemodynamic changes will be assessed after insertion of airway device at baseline,every 1 minute until 5 minutes,every 5 minutes until 30 minutes,every 10minutes until the end of surgery.Side effects like blood on removal of device,hoarseness,dysphagia & sore throat will be noted immediately after removing the airway device & 24 hours after surgery. 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   18/03/2024 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
                              Endotracheal intubation is the definitive way of securing the airway during anaesthesia. However, owing to the profound cardiovascular responses and risks of local trauma, in cases of difficult airway scenario and in rare extreme events of unable to intubate, the Supraglottic Airway Devices play a superior role of which I-gel and Laryngeal Mask airway are the two commonly used ones. This will be a randomised clinical trial conducted to compare the airway management with I-gel, Cuffed Laryngeal Mask Airway and Cuffed Endotracheal tube in patients undergoing surgery under general anaesthesia.
                           A total of 150 patients, aged 18-60 years of either sex , undergoing elective surgical procedures under general anaesthesia, with American Society of Anaesthesiologists (ASA) physical status I and II, fulfilling the inclusion criteria and willing to give consent will be enrolled in the study. They will be randomly allocated into three groups, Group A, Group B and Group C whose airway will be secured by I-gel, Cuffed Laryngeal Mask Airway and Cuffed Endotracheal Tube respectively. The number of insertion attempts, ease of insertion and insertion time will be noted and compared in each case.Hemodynamic changes and side effects after device insertion like blood on device removal,hoarseness,dysphagia and sorethroat will be noted and compared.
                       The findings and observations made during the entire study will be tabulated,graphically depicted whenever possible,statistically analysed and inference will be drawn.
 
Close