| CTRI Number |
CTRI/2023/08/056579 [Registered on: 17/08/2023] Trial Registered Prospectively |
| Last Modified On: |
19/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of airway tube in gynaecological surgeries |
|
Scientific Title of Study
|
AComparative prospective study of laryngeal mask airway(LMA)protector and supreme in laproscopic gynaecological abdominal surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DRharsha hemraj narkhede |
| Designation |
Associte professor |
| Affiliation |
Post Graduate Institute of Yashwantrao Chavan Medical Hospital |
| Address |
Dhanwantari OT,1st Floor Department of Anaesthesiology Postgraduate institute of Yashwantrao Chavan Medical Hospital PIMPRI PUNE
Pune
MAHARASHTRA
411019
India |
| Phone |
9820120440 |
| Fax |
|
| Email |
hhnarkhede@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRharsha hemraj narkhede |
| Designation |
Associte professor |
| Affiliation |
Post Graduate Institute of Yashwantrao Chavan Medical Hospital |
| Address |
Dhanwantari OT,1st Floor Department of Anaesthesiology Postgraduate institute of Yashwantrao Chavan Medical Hospital PIMPRI PUNE
Pune
MAHARASHTRA
411019
India |
| Phone |
9820120440 |
| Fax |
|
| Email |
hhnarkhede@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrAfreen Ansari |
| Designation |
PG Resident |
| Affiliation |
Post Graduate Institute of Yashwantrao Chavan Medical Hospital |
| Address |
Dhanwantari OT,1st Floor Department of Anaesthesiology Postgraduate institute of Yashwantrao Chavan Medical Hospital PIMPRI PUNE
Pune
MAHARASHTRA
411019
India |
| Phone |
9579265600 |
| Fax |
|
| Email |
afrinansari29@gmail.com |
|
|
Source of Monetary or Material Support
|
| PostGraduate Institute of Yashwantrao Chavan Medical PostGraduate Institute of Yahwantrao Chavan Hospital ,Sant Tukaram Nagar PIMPRI PUNE PIMPRI PUNE |
|
|
Primary Sponsor
|
| Name |
Post Graduate Institute of YCMH |
| Address |
Department of Anaesthesia Postgraduate institute yashwantrao chavan medical college Sant Tukaram Nagar Pimpri Pune |
| 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 |
| DrAfreen Ansari |
PostGraduate Institute of Yashwantrao Chavan Medical Hospital |
Anesthesia department,first foor Dhanwantari OT,santtukaram nagar PIMPRI PUNE
Pune
MAHARASHTRA |
9820120440
afrinansari29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Post Graduate Intitute of Yashwantrao Chavan Hospital ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N00-N99||Diseases of the genitourinary system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
ASA-1,ASA-2
of laproscopic Tubal ligation |
|
| ExclusionCriteria |
| Details |
ASA3,ASA-4
BMI more than 35
Anticipated difficult intubation
risk of aspiration |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess ease of insertion in terms of time taken for insertion |
baseline during procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Comparison of oropharyngeal leak pressure
ease of gastric tube insertion
postoperative blood stain
postoperative sore throat |
From procedure till 24 hours after postsurgery |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/08/2023 |
| Date of Study Completion (India) |
28/02/2024 |
| Date of First Enrollment (Global) |
20/08/2023 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
Ongoing |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
This observational cross sectional study will be conducted after ethical and ctri approval.The study contains two groups in which two different LMA protector and LMA supreme will be compared in terms of Insertion time.number of attempts,number of gastric tube attempts,Leak pressure and blood stained or any other complication.We will observed these results in elective gynaecological laprocopic surgery. |