| CTRI Number |
CTRI/2020/06/025534 [Registered on: 02/06/2020] Trial Registered Prospectively |
| Last Modified On: |
01/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between two supraglottic airway devices i.e i-gel and LMA supreme about how easy they are use and manage airway in patients having difficult airway undergoing laparoscopic cholecystectomy
|
|
Scientific Title of Study
|
I-GEL vs SUPREME LMA: A COMPARISON BETWEEN TWO
SUPRAGLOTTIC AIRWAY DEVICES IN AIRWAY
MANAGEMENT OF MPS III/IV PATIENTS COMING FOR
LAPAROSCOPIC CHOLECYSTECTOMY
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kartik Syal |
| Designation |
Associate Professor |
| Affiliation |
Department of Anaesthesiology and critical care,Indira Gandhi medical college,Shimla |
| Address |
Associate Professor
Dept of Anaesthesiology
Indira Gandhi medical college
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418485155 |
| Fax |
|
| Email |
kartik.syal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Kartik Syal |
| Designation |
Associate Professor |
| Affiliation |
Dept of Anaesthesiology and critical care, Indira Gandhi medical college,Shimla |
| Address |
Associate Professor
Dept of Anaesthesiology
Indira Gandhi medical college
Shimla
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418485155 |
| Fax |
|
| Email |
kartik.syal@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAnil Kumar Y R |
| Designation |
Junior resident |
| Affiliation |
Dept of Anaesthesiology and critical care, Indira Gandhi medical college,Shimla |
| Address |
junior resident
Dept of anaesthesia and critical care
IGMC
Shimla-171001
Shimla
HIMACHAL PRADESH
171001
India |
| Phone |
9418485155 |
| Fax |
|
| Email |
anilkumar.yr.puru@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Anil Kumar Y R
Junior Resident
Department of Anaesthesiology and critical care
Indira Gandhi medical college
Shimla-171001
|
|
|
Primary Sponsor
|
| Name |
Indira Gandhi medical college |
| Address |
Shimla-171001
Himachal Pradesh |
| 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 |
| DrKartik Syal |
Indira Gandhi Medical College |
Department of anaesthesiology
C block
Indira Gandhi Medical college
Shimla
HIMACHAL PRADESH |
9418485155
kartik.syal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IGMC ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
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Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
I-gel,LMA supreme |
Comparing above mentioned devices regarding insertion time,Airway leak pressure,hemodynamic responsive and oropharyngeal trauma |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients giving consent for participating in the study.
Patients with the age of 18- 50 years who are ASA I and weighing between 50-70 kg coming for elective laparoscopic cholecystectomy having MPS 3/4. |
|
| ExclusionCriteria |
| Details |
Patients having abnormal airway anatomy, tonsillar hypertrophy, hematoma and abscess.
History of any condition which increase the risk of regurgitation of gastric contents-Full stomach (less then 8 hours fasting), uncertainty about intake of food or drink Trauma Intra-abdominal pathology like intestinal obstruction, peritonitis, gastric paresis. Diabetes (gastro paresis diabeticorum) Uremia (uremic enteropathy) Esophageal disease like symptomatic reflux motility disorder Pregnancy |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) 2) To compare and evaluate ease and success of airway management with these two devices with respect to total time taken for insertion, number of attempts and failure rate. To compare the airway seal pressures of two devices. |
Insertion time-After induction of patient
Airway seal pressure- 2 minutes after insertion of device |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 1) 2) 3) To compare hemodynamic response to insertion of i-gel and LMA supreme. To check whether pneumoperitoneum causes leak with these supraglottic airways To compare the incidence of oropharyngeal trauma and of sore throat and hoarseness postoperatively among patients of both the groups. |
Hemodynamic response- Heart rate,MAP is recorded during first 7 minutes every minute after insertion
Leak after Pneumoperitoneum- checked after pneumoperitoneum around 10 minutes after insertion
Oropharyngeal trauma- checked after removal of device
Sorethroat,Hoarseness of voice - checked after 24 hours postoperatively in ward |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
02/06/2020 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is about comparison between two second generaton supraglottic airway devices i.e I-gel and LMA supreme in regarding ease and success of airway management and airway seal pressures as primary objectives. Hemodynamc responses after insertion,ease of gastric tube insertion,leak after pneumoperitoneum and incidence of oropharyngeal trauma,sorethroat,hoarseness of voice are observed between two devices as secondary objectives |