| CTRI Number |
CTRI/2024/03/064875 [Registered on: 28/03/2024] Trial Registered Prospectively |
| Last Modified On: |
27/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [Anaesthesia/surgery] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare ultrasound guided hyomental distance method with weight based method to select laryngeal mask airway size in adult patients undergoing surgery |
|
Scientific Title of Study
|
Comparison of weight based method and ultrasound guided hyomental distance method for selection of Proseal laryngeal mask airway size in adult patients posted for elective surgery under general anaesthesia |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashmi Rani |
| Designation |
PG student |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
304, DEPARTMENT OF ANAESTHESIA
PGIMER BUILDING
ABVIMS and DR RML HOSPITAL
Central
DELHI
110001
India |
| Phone |
7903402869 |
| Fax |
|
| Email |
rashmi08092000@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sangeeta Yadav |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
304, DEPARTMENT OF ANAESTHESIA
PGIMER BUILDING
ABVIMS and DR RML HOSPITAL
DELHI
110001
India |
| Phone |
9871386600 |
| Fax |
|
| Email |
sangiydv@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashmi Rani |
| Designation |
PG student |
| Affiliation |
ABVIMS and Dr RML Hospital |
| Address |
304, Department of Anaesthesia
PGIMER building
ABVIMS and DR RML HOSPITAL
DELHI
110001
India |
| Phone |
7903402869 |
| Fax |
|
| Email |
rashmi08092000@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr RML Hospital
110001 |
|
|
Primary Sponsor
|
| Name |
Dr RML Hospital delhi |
| Address |
ABVIMS and Dr RML Hospital
Pincode-110001 |
| 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 Rashmi Rani |
ABVIMS and Dr RML Hospital |
Department of Anesthesiology
Dr RML Hospital
New Delhi 110001
Central
DELHI |
7903402869
rashmi08092000@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The institutional Ethics committee ABVIMS,Dr.RML Hospital,New DelhiRML Hosp |
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 |
weight based method and ultrasound guided hyomental distance method |
Group A- weight based method for selection of Proseal laryngeal mask airway
Group B-ultrasound guided hyomental distance method for selection of Proseal laryngeal mask airway |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-60 years
ASA grade I, II
Either sex
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Successful insertion (%) of predicted size of Proseal LMA in both the groups |
From insertion to placement of LMA before surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. number of attempts for LMA placement
2. time taken for successful placement of LMA
3. Incidence of oral injury
|
From assessment & Insertion of LMA till removal of LMA immediately after surgery |
|
|
Target Sample Size
|
Total Sample Size="116"
Sample Size from India="116"
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)
|
07/04/2024 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Aim: To compare weight-based method and ultrasound guided Hyomental distance (HMD) method for selection of Proseal LMA size in adult patients posted for elective surgery under general anaesthesia Primary objective: To compare weight-based method and ultrasound guided HMD method for selection of Proseal LMA size 1st attempt success rate in adult patients posted for elective surgery under general anaesthesia Secondary objective: To compare 1. Number of attempts taken for successful placement of LMA 2. Time taken for optimal insertion of LMA 3. Post operative oral injury
|