| CTRI Number |
CTRI/2024/02/063288 [Registered on: 29/02/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two airway devices to see which is better to give anaesthesia in laparoscopic surgeries |
|
Scientific Title of Study
|
Comparison of LMA ProSeal and LMA ProtectorTM as airway device in laparoscopic surgeries - a randomized controlled trial |
| 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 Aditi Suri |
| Designation |
Assistant professor |
| Affiliation |
ALL india institute of medical sciences, new delhi |
| Address |
Department of anaesthesia
AIIMS
New Delhi
New Delhi
DELHI
110024
India |
| Phone |
8800798097 |
| Fax |
|
| Email |
aditisuri19@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bikash Ray |
| Designation |
Additional professor |
| Affiliation |
All india institute of medical sciences, new delhi |
| Address |
Department of anaesthesia
AIIMS
New Delhi
New Delhi
DELHI
110024
India |
| Phone |
9899323110 |
| Fax |
|
| Email |
bikashray.aiims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bikash Ray |
| Designation |
Additional professor |
| Affiliation |
All india institute of medical sciences, new delhi |
| Address |
Department of anaesthesia
AIIMS
New Delhi
DELHI
110024
India |
| Phone |
9899323110 |
| Fax |
|
| Email |
bikashray.aiims@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of anaesthesia
AIIMS
New Delhi |
|
|
Primary Sponsor
|
| Name |
Dr Aditi Suri |
| Address |
Department of anaesthesia
5th Floor
Main building
AIIMS
New Delhi |
| Type of Sponsor |
Other [Self] |
|
|
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 Aditi Suri |
All india institute of medical sciences |
Operation theatre 6th floor
Surgical block
AIIMS
New Delhi
New Delhi
DELHI |
8800798097
aditisuri19@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee, All India Institute of medical sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K00-K95||Diseases of the digestive system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
LMA proseal |
LMA proseal as airway device in laparoscopic surgeries
The device will be used intraoperatively only during the surgery for a surgery lasting less than 4 hours |
| Intervention |
LMA protector |
LMA protector as airway device in laparoscopic surgeries
lma protector is a new LMA airway device that provides better seal pressures and better protection against regurgitation or aspiration during laparoscopic surgeries.
The device will be used intraoperatively only during the surgery for a surgery lasting less than 4 hours |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ASA class 1 and 2
Patients undergoing laparoscopic surgeries
Duration of surgery less than 4 h
Expected blood loss less than 300 ml. |
|
| ExclusionCriteria |
| Details |
Patients who deny consent
Anticipated difficult airway
Increased risk of aspiration (Full stomach , hiatus hernia , gastroesophageal reflux disease) |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
primary outcome -oropharyngeal leak pressure
secondary outcome- Time to insertion of the LMA
Postoperative sore throat
Fiberoptic score for correct placement
Ease of insertion
Adverse airway complications
peak airway pressures
Patient satisfaction score
Operator satisfaction score
Cost effective analysis of the two devices |
primary outcome -oropharyngeal leak pressure measured in both groups after insertion of LMA
Time to insertion of the LMA will be time from picking up LMA till first visualisation of EtC02 graph
Postoperative sore throat - assessed immediately postoperatively and on POD1
Fiberoptic score for correct placement - done immediately after placement of the LMA
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
secondary outcome- Time to insertion of the LMA
Postoperative sore throat
Fiberoptic score for correct placement
Ease of insertion
Adverse airway complications
peak airway pressures
Patient satisfaction score
Operator satisfaction score
Cost effective analysis of the two devices |
time of insertion will be time from picking up LMA to first appearance of etco2 graph
post op sore throat: measures immediately post op, 4. hrs post op and on post day 1 |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
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)
|
15/04/2024 |
| 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="0"
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
|
LMA ® Protector™ is a recently developed second generation supraglottic airway device that has been designed to provide superior protection against gastric reflux and high OLP. It is a single use, silicone airway device. The silicone cuff conforms to the airway anatomy and achieves higher seal pressures and lesser sore throat compared to PVC cuffs.(2)(3) No studies till date have attempted to compare the efficacy of LMA®ProSeal and LMA®Protector™. This study will therefore compare LMA®ProSeal and LMA®Protector™ as airway devices in laparoscopic surgeries. Use of an airway device with better OLP and protection against regurgitation, lower sore throat will improve patient safety and perioperative outcomes. |