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CTRI Number  CTRI/2024/05/066827 [Registered on: 06/05/2024] Trial Registered Prospectively
Last Modified On: 06/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Single Arm Study 
Public Title of Study   Study to see the working of an airway device to control breathing during surgery for removal of gall bladder  
Scientific Title of Study   Efficacy of LMA Protector in laparoscopic cholecystectomy 
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 Yammini R 
Designation  Junior Resident  
Affiliation  MS Ramaiah Medical College 
Address  Department of Anaesthesiology MS Ramaiah Medical college MSRIT Post New BEL Road Bangalore
MSRIT Post New BEL Road Bangalore 560054
Bangalore
KARNATAKA
560054
India 
Phone  9886196261  
Fax    
Email  yamminireddy75@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Tejesh C A 
Designation  Professor 
Affiliation  MS Ramaiah Medical college 
Address  Department of Anaesthesiology M S Ramaiah Medical College MSRIT Post New BEL road Bangalore 560054

Bangalore
KARNATAKA
560054
India 
Phone  9886481848  
Fax    
Email  drtejeshca@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Tejesh C A 
Designation  Professor 
Affiliation  MS Ramaiah Medical college 
Address  Department of Anaesthesiology M S Ramaiah Medical College MSRIT Post New BEL road Bangalore 560054

Bangalore
KARNATAKA
560054
India 
Phone  9886481848  
Fax    
Email  drtejeshca@yahoo.com  
 
Source of Monetary or Material Support  
MS Ramaiah Medical College MSRIT Post New BEL Road Bangalore 560054 
 
Primary Sponsor  
Name  MS Ramaiah medical college 
Address  MSRIT Post New BEL road Bangalore 560064 
Type of Sponsor  Private 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 Yammini R  MS Ramaiah Medical College Hospital  Department of Anaesthesiology MS Ramaiah Medical College MSRIT Post New BEL Road Bangalore 560064
Bangalore
KARNATAKA 		 9886196261

yamminireddy75@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Ramaiah medical college Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K800||Calculus of gallbladder with acutecholecystitis, (2) ICD-10 Condition: K801||Calculus of gallbladder with othercholecystitis, (3) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (4) ICD-10 Condition: K804||Calculus of bile duct with cholecystitis, (5) ICD-10 Condition: K806||Calculus of gallbladder and bile duct with cholecystitis, (6) ICD-10 Condition: K807||Calculus of gallbladder and bile duct without cholecystitis, (7) ICD-10 Condition: K808||Other cholelithiasis, (8) ICD-10 Condition: K810||Acute cholecystitis, (9) ICD-10 Condition: K811||Chronic cholecystitis, (10) ICD-10 Condition: K812||Acute cholecystitis with chronic cholecystitis, (11) ICD-10 Condition: K819||Cholecystitis, unspecified, (12) ICD-10 Condition: K820||Obstruction of gallbladder, (13) ICD-10 Condition: K821||Hydrops of gallbladder, (14) ICD-10 Condition: K822||Perforation of gallbladder, (15) ICD-10 Condition: K823||Fistula of gallbladder, (16) ICD-10 Condition: K824||Cholesterolosis of gallbladder, (17) ICD-10 Condition: K828||Other specified diseases of gallbladder, (18) ICD-10 Condition: K829||Disease of gallbladder, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  NIL  NIL 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  American society of Anaesthesiologists ASA physical status 1 and 2 patients undergoing laparoscopic cholecystectomy 
 
ExclusionCriteria 
Details  BMI more than 30 kg/m2
Weight more than 100 kg
Gastro-oesophageal reflux disease
Known or anticipated difficult airway
Upper airway pathology
Recent upper respiratory tract infection Mouth opening less than 2 cm
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the efficacy of LMA® Protectorâ„¢ in laparoscopic cholecystectomy  5minutes after the end of laparoscopic cholecystectomy 
 
Secondary Outcome  
Outcome  TimePoints 
Ease of insertion  2 minutes after insertion of LMA 
Number of attempts of insertion with LMA  5minutes after insertion of LMA 
Oropharyngeal leak pressure with LMA  1minute after insertion of LMA 
Ease of gastric tube insertion  3minutes after insertion of LMA 
Position of LMA® Protectorâ„¢ in relation to laryngeal inlet  2 minutes after insertion of LMA 
 
Target Sample Size   Total Sample Size="87"
Sample Size from India="87" 
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)   31/05/2024 
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="2"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  yamminireddy75@gmail.com Will be provided on request by email

  6. For how long will this data be available start date provided 01-07-2027 and end date provided 01-07-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Supraglottic airway devices (SADs) have grown in popularity for airway management since their introduction into the practice of clinical anaesthesia. Laparoscopic cholecystectomy is a commonly performed surgical procedure and is usually carried out under general anaesthesia with endotracheal intubation. Supraglottic airway devices have been used as an alternative to endotracheal intubation in laparoscopic surgeries. However, the concerns with the use of SADs in laparoscopic surgery include potential risk of regurgitation, aspiration, and inadequate ventilation from pneumoperitoneum induced changes in airway pressure and pulmonary compliance.

The oropharyngeal leak pressure (OLP) or sealing pressure is a measure of the capability of a SAD to protect against the risk of aspiration as well as to achieve adequate positive pressure ventilation.  There were functional improvements implemented to newer SAD.The LMA® Protectorâ„¢ Cuff Pilotâ„¢ (Teleflex Medical Europe Ltd, Athlone, Ireland) is a recently introduced second generation SAD made of medical grade silicone that provides access as well as functional separation of respiratory and digestive tracts. The medical grade silicone inflatable cuff is thought to improve the ability of LMA® Protectorâ„¢ to provide high OLP and effective ventilation.

Currently there is paucity of literature detailing the efficacy of LMA® Protector™ in laparoscopic surgeries and hence this study is designed to evaluate its role in laparoscopic cholecystectomy with the hypothesis that LMA® Protector™ may be efficacious in laparoscopic cholecystectomy.

 
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