| CTRI Number |
CTRI/2024/05/067376 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
14/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two second generation Supraglottic Airways for placement and intubation-Blockbuster and Igel |
|
Scientific Title of Study
|
Comparison of supraglottic airway devices, blockbuster LMA and I-gel LMA for ease of insertion and as a conduit for endotracheal intubation in adult patients undergoing abdominal surgery |
| 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 SUSHRUTA CHAKRABORTY |
| Designation |
Post Graduate Trainee |
| Affiliation |
IPGMER AND SSKM |
| Address |
IPGMER
Department of Anaesthesiology
244AJC Bose road
kolkata-700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9432527809 |
| Fax |
|
| Email |
sushrutachakraborty1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MAITREYEE MUKHERJEE |
| Designation |
AssociateProfessor , Department of Anaesthesiology |
| Affiliation |
IPGMER AND SSKM |
| Address |
IPGMER
Department of Anaesthesiology
244AJC Bose road
kolkata-700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830415924 |
| Fax |
|
| Email |
maitreyee1980.mm@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR MAITREYEE MUKHERJEE |
| Designation |
AssociateProfessor , Department of Anaesthesiology |
| Affiliation |
IPGMER AND SSKM |
| Address |
IPGMER
Department of Anaesthesiology
244AJC Bose road
kolkata-700020
Kolkata
WEST BENGAL
700020
India |
| Phone |
9830415924 |
| Fax |
|
| Email |
maitreyee1980.mm@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, IPGMER, 244, AJC bose road, kolkata-700020 , India |
|
|
Primary Sponsor
|
| Name |
Department of Anaesthesiology, IPGMER |
| Address |
IPGMER
Department of Anaesthesiology
244AJC Bose road
kolkata-700020 |
| 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 sushruta chakraborty |
INSTITUTE OF POST GRADUATE MEDICAL EDUCATION & RESEARCH |
244 AJC Bose road.
Department of Anesthesiology
IPGMER
kolkate-700020,
Kolkata
WEST BENGAL |
9432527809
sushrutachakraborty1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IPGME&r Research Oversight 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 |
| Intervention |
BLOCKBUSTER LMA |
To determine ease of insertion of blockbuster LMA and success rate of its use as a conduit for intubation just after induction of anaesthesia in patients undergoing abdominal surgery. As the intervention involves placement of supraglottic airway there is no dose for the intervention. Duration of the intervention is to be determined from the study and apporaximately the duration is 1 minute |
| Comparator Agent |
I-Gel |
To determine ease of insertion of Igel and success rate of its use a Conduit for intubation after induction of anaesthesia in patients undergoing abdominal surgery. As the intervention involves placement of supraglottic airway, there is no dose for this. Duration is to be determined from the study and apporximately the duration is 1 minute |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Adult patient undergoing elective abdominal surgery under general anesthesia requiring intubation
2. patients who have given written informed consent to participate in this study |
|
| ExclusionCriteria |
| Details |
1. known congenital deformity/syndrome.
2. oropharyngeal pathology.
3. Craniofacial anomalies.
4. patient at higher risk of pulmonary aspiration.
5. patient with known cardiovascular, pulmonary,
hepatic, renal, neurological,
endocrinologicaldisease.
6. A known/predicted difficult airway |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of insertion time of Blockbuster LMA versus IGEL |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Comparison of ease of insertion of BlockBuster LMA versus. IGEL
2. Comparison of successful placement of ET tube through BlockBuster LMA & IGEL
3. Comparison of insertion time of ET tube through Blokbuster LMA & IGEL |
at baseline |
|
|
Target Sample Size
|
Total Sample Size="62"
Sample Size from India="62"
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)
|
25/05/2024 |
| 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
|
Securing airway is a vital responsibility of anaesthesiologist. Supra glottic airway devices serves as a bridge between mask and endo tracheal tube. I gel , a cuffless supra glottic device has been in use since decade. Blockbuster LMA a novel 2nd generation supra glottic device provides an alternative to Igel and also claims to provide conduit for endotracheal intubation. This study does the comparision between IGel and Blockbuster on the basis of insertion time and as a conduit for endotracheal intubation. |