| 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
|
|
|
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
|
|
|
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- 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.
- 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.
- 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 |