| CTRI Number |
CTRI/2024/07/071153 [Registered on: 23/07/2024] Trial Registered Prospectively |
| Last Modified On: |
11/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
An observational study on the success rate in placement of Block Buster LMA(BBLMA) in blind endotracheal intubation |
|
Scientific Title of Study
|
performance of blockbuster LMA for ease of endotracheal intubation |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hariharan Lyla Manojji |
| Designation |
post grauadate |
| Affiliation |
Sree Balaji Medical College |
| Address |
21/B malangadhturam 3rd street
Zameen Pallavaram
Chennai 600043.
7, CLC Works Road, Chromepet, Chennai- 44
Chennai
TAMIL NADU
600043
India |
| Phone |
9940637463 |
| Fax |
|
| Email |
manojji02@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vidhya |
| Designation |
professor |
| Affiliation |
sree balaji medical college and hospital |
| Address |
sree balaji medical college and hospital
no.7 clc works road
chrompet
chennai 600044.
Department of Anaesthesia, 3rd floor, Sree Balaji Medical College and Hospital
no.7 clc works road
chrompet
chennai 600044.
Chennai
TAMIL NADU
600044
India |
| Phone |
9597836540 |
| Fax |
|
| Email |
drvidhya.subramanian@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Annu Theagrajan |
| Designation |
Associate professor |
| Affiliation |
sree balaji medical college and hospital |
| Address |
sree balaji medical college and hospital
no.7 clc works road
chrompet
chennai 600044.
Department of Anaesthesia, 3rd floor, Sree Balaji Medical College and Hospital
no.7 clc works road
chrompet
chennai 600044.
Chennai
TAMIL NADU
600044
India |
| Phone |
9597836540 |
| Fax |
|
| Email |
drannuprahlad@gmail.com |
|
|
Source of Monetary or Material Support
|
| sree Balaji Medical College and Hospital, |
|
|
Primary Sponsor
|
| Name |
sree Balaji Medical college and Hospital |
| Address |
no.7 clc works road, chrompet.
chennai 60044. |
| Type of Sponsor |
Private 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 hariharan lyla manojji |
sree balaji medical college and hospital |
Operation theatre complex, 4th floor, Dept of Anaesthesia, sree Balaji Medical college and Hospital
no.7 clc works road
chrompet
chennai 600044.
Chennai
TAMIL NADU |
9940637463
manojji02@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics committee and |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
patients undergoing surgery under general anaesthesia |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
all patients undergoing general anaesthesia.
ASA I and II. |
|
| ExclusionCriteria |
| Details |
patient refusal.
ASA III, IV.
rapid sequence intubation.
weight loss 30kg and more than 90kg.
mouth opening less than 2 fingers.
cases requiring nasal intubation.
emergency cases.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the success rate of blind intubation using Block Buster LMA. |
1. insertion of LMA,
2. insertion of endotracheal tube and confirmation of placement- 2minutes |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| ease & time taken for intubation, postoperative sore throat, hoarseness of voice & trauma. |
1. at the end of surgery
2. 6 hours post operatively
3. 12 hours post operatively |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
16/08/2024 |
| Date of Study Completion (India) |
14/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Endotracheal
intubation is the definitive airway for ventilation and to prevent aspiration,
during general anaesthesia. The invention of supra glottic devices in 1981 changed
the focus of airway management, from intubation to oxygenation and ventilation.
With progress of time, supra glottic devices with advanced features like
anatomical similarity, intubation facility increased cuff volume to have good
sealing pressure. They may be used as a temporary method to maintain an open
airway during the administration of anaesthesia or as an immediate life-saving
measure in a patient with a difficult or failed airway.
A newer LMA called Tourens BlockBuster® LMA
invented in 2012 has been gaining popularity to provide increased safety and
quality of anaesthesia; it is advantageous in providing ventilation, intubation
and it also has inlet and outlet for gastric channel and with sputum collection
device. |