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CTRI Number  CTRI/2024/07/070136 [Registered on: 07/07/2024] Trial Registered Prospectively
Last Modified On: 25/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Whether LMA Protector is better than I Gel for airway management in obese patients undergoing laparoscopic cholecystectomy 
Scientific Title of Study   Comparison of oropharyngeal leak pressure between supraglottic airway devices LMA Protector and I-Gel® in obese patients during laparoscopic cholecystectomy: A randomized control 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  Kasturi Das 
Designation  Junior resident 
Affiliation  AIIMSS Patna 
Address  Department of Anaesthesiology , OT Complex , 5th floor , AIIMS Patna , Phulwarisharif , Patna , Bihar , India

Patna
BIHAR
801507
India 
Phone  8638071837  
Fax    
Email  kasturid370@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Abhyuday Kumar 
Designation  Associate Professor 
Affiliation  AIIMS Patna 
Address  Department of Anaesthesiology , OT Complex , 5th floor , AIIMS Patna , Phulwarisharif , Patna , Bihar , India

Patna
BIHAR
801507
India 
Phone  9013512403  
Fax    
Email  drabhyudaykumar@aiimspatna.org  
 
Details of Contact Person
Public Query
 
Name  Dr Abhyuday Kumar 
Designation  Associate Professor 
Affiliation  AIIMS Patna 
Address  Department of Anaesthesiology , OT Complex , 5th floor , AIIMS Patna , Phulwarisharif , Patna , Bihar , India

Patna
BIHAR
801507
India 
Phone  9013512403  
Fax    
Email  drabhyudaykumar@aiimspatna.org  
 
Source of Monetary or Material Support  
Department of Anaesthesiology , All India Institute of Medical Sciences , Patna , Phulwarisharif , Bihar , India , Pin : 801507 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences , Patna 
Address  Department of Anaesthesiology , OT Complex , 5th floor , AIIMS Patna, Phulwarisharif , Patna , Bihar , Pin : 801507 , India 
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 Kasturi Das  All India Institute of Medical Sciences , Patna  Department of Anaesthesiology , OT Complex , OT no 4/9/6 , Patna , Bihar
Patna
BIHAR 
8638071837

kasturid370@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee , AIIMS Patna  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 
Comparator Agent  I gel®  Oropharyngeal leak pressure will be measured by closing the APL valve and opening fresh gas flow at 3l/min. Two readings of oropharyngeal leak pressure and peak pressure will be taken , one after insertion and successful placement of SAD(T1) and the other 15 minutes after pneumoperitoneum and reverse trendelenberg position(T2) 
Intervention  LMA Protector  Oropharyngeal leak pressure will be measured by closing the APL valve and opening fresh gas flow at 3l/min. Two readings of oropharyngeal leak pressure and peak pressure will be taken , one after insertion and successful placement of SAD(T1) and the other 15 minutes after pneumoperitoneum and reverse trendelenberg position(T2) 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Obese patients
2. Age 18 to 60 years
3. ASA Physical status I and II planned for elective laparoscopic cholecystectomy 
 
ExclusionCriteria 
Details  1. Patient refusal
2. Anticipated difficult airway
3. History of gastroesophageal reflux diseases
Patients with previous abdominal surgery and/or
comorbidities that would affect surgical time
time under anaesthesia
4. Expected duration of surgery is more than 3 hours
5. Any surgery with expected postoperative ICU admission
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Oropharyngeal leak pressure  1. Before pneumoperitoneum
2. 15 minutes after pneumoperitoneum


 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare
The peak pressure before and after pneumoperitoneum
Fiberoptic glottic views
Insertion attempts
Insertion time
Number and type of airway manipulation
Perioperative and postoperative anaesthesia-related problems
 
Intra operative 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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)   15/07/2024 
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
    Response -  Statistical Analysis Plan

  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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response (Others) -  Data will be provided to the researcher on request by mail (kasturid370@gmail.com) by the primary investigator after approval from the institute.

  6. For how long will this data be available start date provided 25-03-2027 and end date provided 25-03-2030?
    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  

The study is a randomised control trial regarding the comparison of oropharyngeal leak pressure between supraglottic airway devices (LMA Protector and I Gel®) in obese patients during laparoscopic cholecystectomy. 

Obese patients frequently have poorer chest compliance because of their thick chest walls and require higher peak inspiratory pressures when positive pressure ventilation is implemented. Laparoscopic surgeries in obese patients will require higher airway pressure during mechanical ventilation, thus requiring a supraglottic airway device (SAD) with higher oropharyngeal leak pressures (OLP).

Limited research has been conducted to compare the oropharyngeal leak pressure of different supraglottic airway devices, specifically in obese patients undergoing laparoscopic cholecystectomy.  sample size is calculated based on a study by Chang et al. A sample size of 80 (40 per group) will be taken, considering dropouts and errors in sample size calculation. Convenient sampling is done. The primary objective is to compare the oropharyngeal leak pressure LMA Protector and I gel® in obese patients during laparoscopic cholecystectomy. The secondary objective is to evaluate and compare the peak pressure before and after pneumoperitoneum , Fiberoptic glottic views , Insertion attempts , Insertion time , Number and type of airway manipulation , and perioperative and postoperative anesthesia-related problems. The inclusion criteria is obese patients of 18–60 years of age of ASA Physical status I and II planned for elective laparoscopic cholecystectomy under general anesthesia with a BMI of 30 and above. The exclusion criteria includes Patient refusal , Anticipated difficult airway , History of gastroesophageal reflux diseases , Patients with previous abdominal surgery and/or comorbidities that would affect surgical time, time under anaesthesia , Expected duration of surgery > 3 hours; any surgery with expected postoperative ICU admission. 

 

 

PPSJ. Patients meeting the inclusion criteria will be shifted to the operating room (OR). Upon arrival inside the OR , all ASA standard monitors will be attached and recording of baseline parameters will be noted. Before inducing the patient, sequentially numbered opaque sealed envelopes with allocated groups will be handed over to the anesthesiologist, and the patient will be induced under general anaesthesia. The appropriate size of SAD will be inserted as per the manufacturer’s guidelines. The OLP will be measured by closing the expiratory valve of the circle system at fresh gas flow of 3 l/minutre and noting the airway pressure at which equilibrium will be reached. Two readings of OLP and peak pressure will be taken: one after insertion and successful placement of SAD (T1), and the other 15 minutes after pneumoperitoneum and reverse trendelenberg position.

PP

 

 
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