| CTRI Number |
CTRI/2024/02/063035 [Registered on: 22/02/2024] Trial Registered Prospectively |
| Last Modified On: |
16/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
a study comparing two airway device |
|
Scientific Title of Study
|
A randomised controlled study to compare the first attempt success rate at insertion of LMA protector TM and i-gel TM in elective surgical procedures |
| 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. L.Geetha Ramalakshmi |
| Designation |
Post Graduate |
| Affiliation |
SRM Medical college hospital and research centre |
| Address |
Room no 1.B block anaesthesia department
SRM Medical college hospital and Research Centre SRM nagar,
Potheri Chengalpattu district Kanchipuram Tamil Nadu - 603203
India Room no 1.B block anaesthesia department
SRM Medical college hospital and Research Centre SRM nagar,
Potheri Chengalpattu district Kanchipuram Tamil Nadu - 603203
India Kancheepuram TAMIL NADU 603203 India |
| Phone |
09944559112 |
| Fax |
|
| Email |
vasanthasaigeetha@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr.R. Balaji |
| Designation |
Professor |
| Affiliation |
SRM Medical college hospital and research centre |
| Address |
Room no 1.B block anaesthesia department
SRM Medical college hospital and Research Centre SRM nagar,
Potheri Chengalpattu district Kanchipuram Tamil Nadu - 603203
India
India Room no 1.B block anaesthesia department
SRM Medical college hospital and Research Centre SRM nagar,
Potheri Chengalpattu district Kanchipuram Tamil Nadu - 603203
India Kancheepuram TAMIL NADU 603203 India |
| Phone |
9677053310 |
| Fax |
|
| Email |
aarbee79@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr.R. Balaji |
| Designation |
Professor |
| Affiliation |
SRM Medical college hospital and research centre |
| Address |
Room no 1.B block anaesthesia department
SRM Medical college hospital and Research Centre SRM nagar,
Potheri Chengalpattu district Kanchipuram Tamil Nadu - 603203
India Room no 1.B block anaesthesia department
SRM Medical college hospital and Research Centre SRM nagar,
Potheri Chengalpattu district Kanchipuram Tamil Nadu - 603203
India Kancheepuram TAMIL NADU 603203 India |
| Phone |
9677053310 |
| Fax |
|
| Email |
aarbee79@gmail.com |
|
|
Source of Monetary or Material Support
|
| SRM Medical college Hospital and Research centre SRM NAGAR Potheri Chengalpattu 603203 |
|
|
Primary Sponsor
|
| Name |
SRM Medical collage Hospital and Research centre |
| Address |
Room no 5, B block,SRM Medical collage hospital and research centre SRM NAGAR,potheri,chengalpattu district kanchipuram, Tamil Nadu-603203 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| DrRBalaji |
SRM Medical College Hospital and Research Centre |
Department of
Anaesthesia 2nd floor
Room no.1 , B
block,SRM Medical
College hospital and
Research centre SRM
Nagar Potheri
Chengalpattu 603203
Kancheepuram
TAMIL NADU Kancheepuram TAMIL NADU |
9677053310
aarbee79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical college hospital and research centre |
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 |
| Intervention |
Group A
|
LMA protector will be inserted and cuff will be inflated at standardized intra cuff pressure of 60cm h2o till the time of attainment of square wave pattern on ETco2 |
| Comparator Agent |
Group B |
i-gel of appropriate size will be inserted and secured. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ASA 1 and ASA 2 patients
All elective procedures
MPC Grade 1 and 2 patients
|
|
| ExclusionCriteria |
| Details |
Patients with Risk of aspiration
Patients with history of GERD
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| First attempt success rate |
0 minute to 1 minute |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
time taken for insertion
number of attempts for successful airway attainment
oropharyndeal leak pressure
gastric tube insertion
blood staining of the device
post operative sorethroat
tongue,lip,teeth and paryngeal mucosa injury |
24 hours |
|
|
Target Sample Size
|
Total Sample Size="110" Sample Size from India="110"
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)
|
04/03/2024 |
| 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="1" 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 - NO
|
|
Brief Summary
|
This study will be performed in patients scheduled to undergo minor surgical procedures under general anaesthesia. A written informed consent will be obtained from the participants. The participants will be allocated into two groups by computer-generated random numbers. Group A is LMA Protector and Group B is i-gel. Anaesthesia premedication and induction will be standardized among the groups. After adequate attainment of intubating conditions, either LMA protector or i-gel will be introduced in their respective groups by postgraduate students who have done a minimum of 25 classic LMA successful insertions. Proper placement of the airway device is confirmed by five-point auscultation and ETCO2 tracings on the capnograph. The time taken and the number of attempts to secure the airway will be noted. At the end of the surgery, SAD will be removed on regaining of adequate consciousness and intact airway reflexes. The surface of the device will be examined for any blood staining and will be recorded. Any episodes of laryngospasm will be documented and managed as per standard protocols. Any complaints of sore throat will be documented. |