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CTRI Number  CTRI/2024/02/062565 [Registered on: 13/02/2024] Trial Registered Prospectively
Last Modified On: 07/02/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   To estimate and compare the degree of gastric insufflation as measured by ultrasound between LMA Protector and i-gel to know risk of gastric aspiration between two devices. 
Scientific Title of Study   comparision of gastric insufflation between LMA Protector and i-gel using ultrsound in adult patients- a randomized controlled 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  Dr Mamta Bhardwaj 
Designation  Professor 
Affiliation  Pt B D Sharma Post Graduate Institute of Medical Sciences Rohtak 
Address  Department of Anaesthesiology and Critical Care PGIMS,Rohtak Rohtak Haryana 124001 India

Rohtak
HARYANA
124001
India 
Phone  9812789476  
Fax    
Email  drbmamta@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Deepika Kumari 
Designation  Junior Resident 
Affiliation  Pt B D Sharma Post Graduate Institute of Medical Sciences Rohtak 
Address  Department of Anaesthesiology and Critical Care , PGIMS Rohtak Haryana 124001 India

Rohtak
HARYANA
124001
India 
Phone  9871523522  
Fax    
Email  dnehaprasad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Deepika Kumari 
Designation  Junior Resident 
Affiliation  Pt BD Sharma Post Graduate Institute of Medical Sciences Rohtak 
Address  Department of Anaesthesiology and Critical Care , PGIMS Rohtak Haryana 124001 India

Rohtak
HARYANA
124001
India 
Phone  9871523522  
Fax    
Email  dnehaprasad@gmail.com  
 
Source of Monetary or Material Support  
Institutional,Pt B D Sharma Post Graduate Institute of Medical Sciences,Rohtak,Haryana 
 
Primary Sponsor  
Name  Pt BD Sharma university of health Sciences PGIMS Rohtak 
Address  Pt BD Sharma university of health Sciences,PGIMS,Rohtak,Haryana 
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 
Dr Deepika kumari  Pt BD Sharma PGIMS, Rohtak  Department of Anaesthesiology and Critical Care , PGIMS Rohtak Haryana 124001 India
Rohtak
HARYANA 		 9871523522

dnehaprasad@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Biomedical Research Ethics Committee,Pt BD Sharma,pgims,rohtak  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients Belonging to the American Society of Anaesthesiology (ASA) I and II, Scheduled for elective surgical procedure under general anesthesia. 
 
ExclusionCriteria 
Details  Patients with upper gastrointestinal problems,known history of gastro-oesophageal reflux disorder, BMI>35, recent upper respiratory tract infection, Mallampatti grade III or IV, pregnancy. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
what will be the difference between the gastric insufflation volume between LMA Protector and i-gel using ultrasound in adult patients.  Assessment of gastric cross sectional area using ultrasound before face mask vwntilation ,after face mask ventilation and at the end of surgery 
 
Secondary Outcome  
Outcome  TimePoints 
oropharyngeal seal pressures, peak aiway pressures,post op complications like sore thoat,blood stains on device,nausea and vomitting  during statistical calculation 
 
Target Sample Size   Total Sample Size="92"
Sample Size from India="92" 
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   N/A 
Date of First Enrollment (India)   18/02/2024 
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="6"
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   A prospective, observational study will be conducted in adult patients 18-60 years of age, of either sex belonging to American society of Anaesthesiologists (ASA) I and II scheduled for elective surgical procedure under general anesthesia. patients with upper gastrointestinal problems, known history of gastroesophageal reflux disorders, pregnancy, BMI>35, recent URTI and mallampatti grade III or IV, and patients refusal to participate will be excluded. The aim of the study is to compare gastric insufflation volume between LMA Protector and I gel using ultrasound. The primary objective is to estimate and compare antral cross-sectional area between two SADs immediately after face mask ventilation and at the end of surgery. The USG parameters will be assessed on the day of surgery before face mask ventilation, after face mask ventilation and at the end of surgery. Data will be compiled and statistical test will be used to obtain the results. 
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