| CTRI Number |
CTRI/2024/03/064261 [Registered on: 18/03/2024] Trial Registered Prospectively |
| Last Modified On: |
16/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To study and compare the two different devices-LMA BlockBuster and i-Gel used for airway patency during General Anaesthesia for surgery in Children |
|
Scientific Title of Study
|
Evaluation and Comparison of insertion of LMA BlockBuster with i-Gel for airway management in children |
| 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 Rajmala Jaiswal |
| Designation |
Senior Professor |
| Affiliation |
Pt. BD Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt. BD Sharma
PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8222897449 |
| Fax |
|
| Email |
para3007@rediffmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Komal Yadav |
| Designation |
Junior Resident |
| Affiliation |
Pt. BD Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt. BD Sharma
PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9899052990 |
| Fax |
|
| Email |
rao.komal96@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Komal Yadav |
| Designation |
Junior Resident |
| Affiliation |
Pt. BD Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, Pt. BD Sharma
PGIMS, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9899052990 |
| Fax |
|
| Email |
rao.komal96@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology and Critical Care, Pt. BD Sharma PGIMS, Rohtak |
|
|
Primary Sponsor
|
| Name |
Pt. BD Sharma PGIMS, Rohtak |
| Address |
Department of Anaesthesiology and Critical Care, PGIMS, Rohtak, Haryana, 124001, India |
| 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 Komal Yadav |
Pt. BD Sharma PGIMS, Rohtak |
Department of Anaesthesiology and Critical Care, Pt. BD Sharma PGIMS, Rohtak
Rohtak
HARYANA |
9899052990
rao.komal96@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics committee, Pt. BD Sharma PGIMS/UHS, Rohtak |
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 Laryngeal Mask Airway |
Blockbuster Laryngeal Mask Airway of size appropriate for the weight of the patient will be used after induction during General Anaesthesia and will be used for 1 to 3 hours of surgery |
| Comparator Agent |
i-Gel |
i-Gel of size appropriate for the weight of the patient will be used after induction during General Anaesthesia for a period of 1 to 3 hours of surgery |
|
|
Inclusion Criteria
|
| Age From |
8.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA category 1 or 2 with MPG I or II undergoing elective surgical procedures under general anaesthesia will be included in the study and appropriate size of the airway devices will be used. |
|
| ExclusionCriteria |
| Details |
Abnormal airway, refusal for informed written consent by the parent/ guardian, inadequate mouth opening (less than 2 finger breadth) |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study and compare the time of insertion of the devices used |
Measured during induction of general anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Number of attempts |
Assessed at baseline |
| Ease of insertion |
Assessed at baseline |
| Oropharyngeal leak pressure |
assessed at baseline |
| Fiberoptic view scoring |
Assessed at baseline |
| Blood stain, Laryngospasm, sore throat, cough, hoarseness of voice |
Measured at extubation & at 1 hour, 3 hours & 6 hours post-operative period |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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 3/ Phase 4 |
|
Date of First Enrollment (India)
|
25/03/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
29/03/2024 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="10"
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
|
The study titled “Evaluation and Comparison of insertion of LMA BlockBuster with i-Gel for airway management in children" will be conducted in the Department of Anaesthesiology and Critical Care, Pt. BD Sharma PGIMS, Rohtak. It will be a prospective randomised single blinded trial. A total of 50 pediatric patients undergoing elective surgical procedure under general anaesthesia belonging to the age group of 8 to 12 years of either gender will be allocated into 2 groups of 25 patients each- group BB (for LMA BlockBuster) and group I (for i-Gel). After taking informed and written consent from the parents/ guardians the patients will be induced for general anaesthesia as per standard guidelines and the device of appropriate size will be used to secure the airway for maintenance throughout the surgery. A fiberoptic bronchoscope will then be passed through the device to check the Cormack- Lahane grading. All the vital observations will be recorded in the record sheet. After the completion of the surgery, the patient will be reversed from general anaesthesia and post-operative complications like blood staining of the device, laryngospasm, sore throat, cough and hoarseness of voice will be observed and managed. |