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CTRI Number  CTRI/2024/02/063035 [Registered on: 22/02/2024] Trial Registered Prospectively
Last Modified On: 16/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   a study comparing two airway device 
Scientific Title of Study   A randomised controlled study to compare the first attempt success rate at insertion of LMA protector TM and i-gel TM in elective surgical procedures 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. L.Geetha Ramalakshmi 
Designation  Post Graduate 
Affiliation  SRM Medical college hospital and research centre 
Address  Room no 1.B block anaesthesia department SRM Medical college hospital and Research Centre SRM nagar, Potheri Chengalpattu district Kanchipuram Tamil Nadu - 603203 India
Room no 1.B block anaesthesia department SRM Medical college hospital and Research Centre SRM nagar, Potheri Chengalpattu district Kanchipuram Tamil Nadu - 603203 India
Kancheepuram
TAMIL NADU
603203
India 
Phone  09944559112  
Fax    
Email  vasanthasaigeetha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr.R. Balaji 
Designation  Professor 
Affiliation  SRM Medical college hospital and research centre 
Address  Room no 1.B block anaesthesia department SRM Medical college hospital and Research Centre SRM nagar, Potheri Chengalpattu district Kanchipuram Tamil Nadu - 603203 India India
Room no 1.B block anaesthesia department SRM Medical college hospital and Research Centre SRM nagar, Potheri Chengalpattu district Kanchipuram Tamil Nadu - 603203 India
Kancheepuram
TAMIL NADU
603203
India 
Phone  9677053310  
Fax    
Email  aarbee79@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr.R. Balaji 
Designation  Professor 
Affiliation  SRM Medical college hospital and research centre 
Address  Room no 1.B block anaesthesia department SRM Medical college hospital and Research Centre SRM nagar, Potheri Chengalpattu district Kanchipuram Tamil Nadu - 603203 India
Room no 1.B block anaesthesia department SRM Medical college hospital and Research Centre SRM nagar, Potheri Chengalpattu district Kanchipuram Tamil Nadu - 603203 India
Kancheepuram
TAMIL NADU
603203
India 
Phone  9677053310  
Fax    
Email  aarbee79@gmail.com  
 
Source of Monetary or Material Support  
SRM Medical college Hospital and Research centre SRM NAGAR Potheri Chengalpattu 603203 
 
Primary Sponsor  
Name  SRM Medical collage Hospital and Research centre 
Address  Room no 5, B block,SRM Medical collage hospital and research centre SRM NAGAR,potheri,chengalpattu district kanchipuram, Tamil Nadu-603203  
Type of Sponsor  Research institution and hospital 
 
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 
DrRBalaji  SRM Medical College Hospital and Research Centre  Department of Anaesthesia 2nd floor Room no.1 , B block,SRM Medical College hospital and Research centre SRM Nagar Potheri Chengalpattu 603203 Kancheepuram TAMIL NADU
Kancheepuram
TAMIL NADU 
9677053310

aarbee79@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SRM Medical college hospital and research centre  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  Group A   LMA protector will be inserted and cuff will be inflated at standardized intra cuff pressure of 60cm h2o till the time of attainment of square wave pattern on ETco2 
Comparator Agent  Group B  i-gel of appropriate size will be inserted and secured. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  ASA 1 and ASA 2 patients
All elective procedures
MPC Grade 1 and 2 patients
 
 
ExclusionCriteria 
Details  Patients with Risk of aspiration
Patients with history of GERD

 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
First attempt success rate  0 minute to 1 minute 
 
Secondary Outcome  
Outcome  TimePoints 
time taken for insertion
number of attempts for successful airway attainment
oropharyndeal leak pressure
gastric tube insertion
blood staining of the device
post operative sorethroat
tongue,lip,teeth and paryngeal mucosa injury 
24 hours 
 
Target Sample Size   Total Sample Size="110"
Sample Size from India="110" 
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 4 
Date of First Enrollment (India)   04/03/2024 
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 Applicable 
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  
This study will be performed in patients scheduled to undergo minor surgical procedures under general anaesthesia. A written informed consent will be obtained from the participants. The participants will be allocated into two groups by computer-generated random numbers. Group A is LMA Protector and Group B is i-gel. Anaesthesia premedication and induction will be standardized among the groups. After adequate attainment of intubating conditions, either LMA protector or i-gel will be introduced in their respective groups by postgraduate students who have done a minimum of 25 classic LMA successful insertions. Proper placement of the airway device is confirmed by five-point auscultation and ETCO2 tracings on the capnograph. The time taken and the number of attempts to secure the airway will be noted. At the end of the surgery, SAD  will be removed on regaining of adequate consciousness and intact airway reflexes. The surface of the device will be examined for any blood staining and will be recorded. Any episodes of laryngospasm will be documented and managed as per standard protocols. Any complaints of sore throat will be documented.
 
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