| CTRI Number |
CTRI/2025/02/080442 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
08/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of two types of airway devices through which patients can breathe as a means to put wind pipe tubes for securing airway |
|
Scientific Title of Study
|
A prospective randomised double blind study comparing the ease of intubation in blockbuster LMA versus intubating LMA as a conduit for blind endotracheal intubation |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gagana B |
| Designation |
Junior resident |
| Affiliation |
Mysore medical college and research institute |
| Address |
Mysore medical college and research institute, department of anesthesiology, 1st floor,Irwin road, next to railway station, Mysore, Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
8197166019 |
| Fax |
|
| Email |
gaganab95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr T K Shashikala |
| Designation |
Professor |
| Affiliation |
Mysore medical college and research institute |
| Address |
Mysore medical college and research institute, department of anesthesiology, 1st floor, Irwin road, next to railway station, Mysore, Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
9148650639 |
| Fax |
|
| Email |
drshi72@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr T K Shashikala |
| Designation |
Professor |
| Affiliation |
Mysore medical college and research institute |
| Address |
Mysore medical college and research institute, department of anesthesiology, 1st floor, Irwin road, next to railway station, Mysore, Karnataka
Mysore
KARNATAKA
570001
India |
| Phone |
9148650639 |
| Fax |
|
| Email |
drshi72@gmail.com |
|
|
Source of Monetary or Material Support
|
| Mysore medical college and research institute, Irwin road, Mysore 570001 |
|
|
Primary Sponsor
|
| Name |
Dr Shashikala T K |
| Address |
Dr Shashikala T K, professor, Department of Anaesthesiology, Mysore medical college and research institute, Mysore |
| 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 Gagana B |
Mysore medical college and research institute |
Department of anaesthesiology, 1rd Floor, KR hospital stone building, Irwin road, mysore
Mysore
KARNATAKA |
8197166019
gaganab95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Mysore Medical college and research institute |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: N288||Other specified disorders of kidney and ureter, (2) ICD-10 Condition: E042||Nontoxic multinodular goiter, (3) ICD-10 Condition: H701||Chronic mastoiditis, (4) ICD-10 Condition: K802||Calculus of gallbladder without cholecystitis, (5) ICD-10 Condition: M959||Acquired deformity of musculoskeletal system, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP (B LMA) |
Blockbuster LMA is inserted after induction with anaesthesia, after obtaining oropharyngeal seal pressure, endotracheal tube will be inserted through this LMA by using LMA specific tube like BLOCKBUSTER tubes and fastrach tubes, after confirmation of position of tube LMA is removed and check ease of intubation |
| Comparator Agent |
GROUP (I LMA) |
Intubating LMA is inserted after induction with anaesthesia, after obtaining oropharyngeal seal pressure, Num 8 PVC endotracheal tube will be inserted through this LMA after confirmation of position of tube LMA is removed and check ease of intubation |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
All ASA I and ASA II patients between 15-55years of age group.
All modified Mallampatti class I and II |
|
| ExclusionCriteria |
| Details |
ASA III and ASA IV patients
Drug allergies
Patients with comorbidities like diabetes, hypertension, cardiovascular, respiratory and neurological disorders |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Time of LMA insertion
Ease of LMA insertion
Oropharyngeal seal pressure
Time of tracheal intubation
|
15mins
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Failed intubation
Sore throat pain
Nausea
Vomiting |
24hours |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
21/02/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
21/02/2025 |
| 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 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
|
A prospective randomised double blind study comparing the ease of intubation in blockbuster LMA versus intubating LMA as a conduit for blind endotracheal intubation as it may guide the difficult intubation and also we are comparing the 2 new generation LMA |