| CTRI Number |
CTRI/2021/12/038687 [Registered on: 16/12/2021] Trial Registered Prospectively |
| Last Modified On: |
15/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Compare Between Two Supraglottic Airway Devices in Anaesthetised, Paralysed Patients |
|
Scientific Title of Study
|
Comparative Evaluation Of Laryngeal Mask Airway Protector Versus Laryngeal Mask Airway Proseal In Anaesthetised, Paralysed Patients |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR Garima Bhatt |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College New Delhi |
| Address |
Room N0 302 Department Of Anaesthesiology and Intensive Care Third Floor BL Taneja Block Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
7578284722 |
| Fax |
|
| Email |
garima.bhatt.25.10.93@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR Kirti Nath Saxena |
| Designation |
Director Professor & Head of Department of Anaesthesiology & Intensive Care MAMC & LNH |
| Affiliation |
Maulana Azad Medical College New Delhi |
| Address |
Room N0 302 Department Of Anaesthesiology and Intensive Care Third Floor BL Taneja Block Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
8383898343 |
| Fax |
|
| Email |
kirtinath@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Garima Bhatt |
| Designation |
Post Graduate Resident |
| Affiliation |
Maulana Azad Medical College New Delhi |
| Address |
Room N0 302 Department Of Anaesthesiology and Intensive Care Third Floor BL Taneja Block Maulana Azad Medical College
Central
DELHI
110002
India |
| Phone |
7578284722 |
| Fax |
|
| Email |
garima.bhatt.25.10.93@gmail.com |
|
|
Source of Monetary or Material Support
|
| OT Block FIRST SECOND and THIRD Floor Maulana Azad Medical College and Lok Nayak Hospital New Delhi |
|
|
Primary Sponsor
|
| Name |
Maulana Azad Medical College |
| Address |
Room no 302 Department of Anaesthesiology and Intensive Care Third Floor BL Taneja Block Maulana Azad Medical College |
| 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 Garima |
Lok Nayak Hospital |
OT Block, Lok Nayak Hospital and associated G.I.P.M.E.R, Guru Nanak Eye Centre, Delhi Gate, Jawahar Lal Nehru Marg
Central
DELHI |
7578284722
garima.bhatt.25.10.93@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 |
LMA Proseal |
Second generation supraglottic airway device,Using sizes 3,4,5 in patient weighing 30-50kg,50-70kg,70-100kg respectively
Duration; 2 hours |
| Intervention |
LMA Protector |
Second generation supraglottic airway device. Using sizes;3,4,5 in patients weighing 30-50kg,50-70kg,70-100kg respectively
Duration; 2 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1) Age 18 to 65 years of either sex.
2) American Society Of Anaesthesiologists(ASA) Class 1 and 2. |
|
| ExclusionCriteria |
| Details |
1) Patients at increased Risk of Aspiration or GERD.
2) BMI >35kg/m2
3) Pregnancy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Insertion Time |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Number of attempts
2.Ease of gastric tube placement
3View on Fibreoptic |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
25/12/2021 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
25/12/2021 |
| 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)?
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
- 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 - Proposals should be directed to [garima.bhatt.25.10.93@gmail.com].
- For how long will this data be available start date provided 29-10-2023 and end date provided 29-06-2026?
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
|
Laryngeal Mask Airway Protector is latest second generation airway device introduced in 2015 combining pharyngeal chamber and dual gastric drainage channels. There is paucity of studies which compared LMA Protector to other supraglottic airway device. The present study is proposed to compare the performance of LMA Protector to LMA Proseal in 250 patients undergoing elective surgeries under anaesthesia. Adult patients aging 18- 65 years of either sex and those belonging to ASA PS I and II who was scheduled to undergo elective surgeries under general anaesthesia with supraglottic device will be recruited for participation in study. Pregnant patients those having BMI >35 kg/m2 and patients at increased risk of aspiration will be excluded. Patients will be randomly allocated into 2 groups ; in group 1 ( LMA Protector group) in group 2 ( LMA Proseal).Standard technique of anaesthesia will be used in both groups. As per group allocation either LMA Protector or LMA Proseal will be used for securing airway of patients. 3 attempts will be allowed for successful placement in either groups. Primary objective will be time taken for successful insertion of LMA Protector and LMA Proseal. Secondary objectives will be ; to compare number of attempts for successful insertion; to compare the ease of insertion of nasogastric tubes through LMA Protector and LMA Proseal; to see correct placement by fibreoptic evaluation. Collected data will be entered in Microsoft excel and then will be analysed and statistically evaluated using SPSS-25.0 version. Appropriate statistical tests will be applied. |