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CTRI Number  CTRI/2022/10/046760 [Registered on: 25/10/2022] Trial Registered Prospectively
Last Modified On: 18/10/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison OF two airway devices used in paients undergoing surgery for gallbladder stone. 
Scientific Title of Study   A Comparative Study of Respiratory mechanics in Patients undergoing day care laparoscopic cholecystectomy using LMA ProSeal vs LMA Protector. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Bimla Sharma 
Designation  Senior Consulant 
Affiliation  sir gangaram hospital  
Address  ROOM NO 10 SSRB 5TH FLOOR INSTITUTE OF ANAESTHESIOLOGY, PAIN AND PERIOPERATIVE MEDicine sir gangaram hospital old rajender nagar new delhi

New Delhi
DELHI
110060
India 
Phone  9810135366  
Fax    
Email  bimsharma1@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Bimla Sharma 
Designation  Senior Consulant 
Affiliation  sir gangaram hospital  
Address  ROOM NO 10 SSRB 5TH FLOOR INSTITUTE OF ANAESTHESIOLOGY, PAIN AND PERIOPERATIVE MEDicine sir gangaram hospital old rajender nagar new delhi

New Delhi
DELHI
110060
India 
Phone  9810135366  
Fax    
Email  bimsharma1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Bimla Sharma 
Designation  Senior Consulant 
Affiliation  sir gangaram hospital  
Address  ROOM NO 10 SSRB 5TH FLOOR INSTITUTE OF ANAESTHESIOLOGY, PAIN AND PERIOPERATIVE MEDicine sir gangaram hospital old rajender nagar new delhi
INSTITUTE OF ANAESTHESIOLOGY, PAIN AND PERIOPERATIVE MEDicine sir gangaram hospital old rajender nagar new delhi
New Delhi
DELHI
110060
India 
Phone  9810135366  
Fax    
Email  bimsharma1@gmail.com  
 
Source of Monetary or Material Support  
Sir Ganga Rm Hospital, New Delhi 
 
Primary Sponsor  
Name  Sir Ganga Ram Hospital  
Address  Old Rajinder Nagar, Sarhadi Gandhi Marg, New Delhi, Delhi 110060 · 
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 
Dr Bimla Sharma  Sir Ganga Ram Hospital, New Delhi  Operation Theatre 5th Floor, SSRB New Building, Sir Ganga Ram Hospital Marg, New Delhi 110060
Central
DELHI 
9810135366

bimsharma1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institional Ethics Committee, SGRH  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: O||Medical and Surgical,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LMA proseal  It is a supraglottic airway device made of medical grade silicon. It has built in drainge tube for gastric drainage which helps in prevention of aspiration. (Duration:30 minutes to 2 hours) 
Intervention  LMA protector  It is a newly developed supraglottic airway device with 2 gastric drainage which helps in preventing aspiration (Duration:30 minutes to 2 hours) 
Comparator Agent  No any  No any 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1. ASA physical status 1 and 2
2. BMI <35 
 
ExclusionCriteria 
Details  1.BMI >35
2. Patient with upper respiratory tract infection
3. Patient at risk of aspiration
4. Anticipated difficult airway
5. Mouth opening less than 2.5 cm
6. Patient with lung disease
patient refusal 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Comparison of dynamic compliance using LMA® ProSealâ„¢ vs. LMA® Protectorâ„¢ in patients undergoing lap cholecystectomy.  1. At insertion of the device
2. At 5 minutes after insertion of the device.
3. At 10 minutes after insertion of the device
4. At the initiation of carboperitoneum
5. At 5 minutes of carboperitoneum
6. At 10 minutes of carboperitoneum
7. At 20 minutes of carboperitoneum
8. At the release of carboperitoneum
9. 5 minutes afterthe release of carboperitoneum
10. 10 minutes after the release of carboperitoneum
 
 
Secondary Outcome  
Outcome  TimePoints 
Comparison of
Airway resistance
Peak airway pressure
Plateau pressure
SpO2
Fibreoptic evaluation of the position of the airway device.
Intraoperative and postoperative complications
 
1. At insertion of the device
2. At 5 minutes after insertion of the device.
3. At 10 minutes after insertion of the device
4. At the initiation of carboperitoneum
5. At 5 minutes of carboperitoneum
6. At 10 minutes of carboperitoneum
7. At 20 minutes of carboperitoneum
8. At the release of carboperitoneum
9. 5 minutes afterthe release of carboperitoneum
10. 10 minutes after the release of carboperitoneum
 
 
Target Sample Size   Total Sample Size="50"
Sample Size from India="50" 
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)   01/11/2022 
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   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Minimally invasive laparoscopic surgery has revolutionized surgical practice and influenced the practice of anaesthesiology. Improvement in surgical and anaesthetic techniques has led to surgeries being performed on an outpatient basis with better pain management,early recovery and short duration of admission.General anaesthesia with controlled ventilation is the technique of choice in laparoscopic surgeries.

The record success of laryngeal mask airway in resuscitation, difficult airway management and anaesthesia lead to the introduction of several supraglottic airway devices (SADs) into clinicalpractice.SADsoffer several advantages over endotracheal tubes including ease of insertion, reduced haemodynamic response,decreased airway tolerance and lesser pharyngolaryngealmorbidity.1-5 The introduction of second-generation SADs having gastric drainage tube provide a better oropharyngeal seal and improved protection against regurgitation and pulmonary aspiration.

LMA®  Protectorâ„¢ is a recently developed SAD  with few published studies on its utility to date. It is made of medical-grade silicone which makes it more flexible and less traumatic than previous LMA devices made up of PVC. It is a single-use second generation SAD designed with a large volume conduit with gastric assess and a fixed curved structure to facilitate insertionand an inflatable airway cuff.6 Additionally, the LMA  Protector is available with a pilot balloon or the integrated cuff pilot that provides easier adjustment of the intracuff pressure.7

Since LMA®  Protectorâ„¢ was introduced in 2015 as the most advanced second-generation device, we want to compare this device with LMA® ProSealâ„¢, one of the most frequently used devices in any institution. Until now, only a few studies have compared the clinical efficacy of the LMA®  Protectorâ„¢ with other SADs.

In this study, we aim to compare the respiratory mechanics with LMA® ProSealâ„¢ vs.LMA®  Protectorâ„¢ in patients undergoing day care laparoscopic cholecystectomy.


 

 
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