| CTRI Number |
CTRI/2025/01/078880 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| 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
|
A Study to Compare Two Devices (LMA Blockbuster and LMA Proseal) for Safe Breathing Support in Children Undergoing Surgery" |
|
Scientific Title of Study
|
Comparison of LMA Blockbuster and LMA Proseal for controlled ventilation in paediatric patients. |
| 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 Vandna Arora |
| Designation |
Associate Professor |
| Affiliation |
Department of Anaesthesia and critical care, Postgraduate Institute of medical sciences, Rohtak |
| Address |
Department of Anaesthesia and critical care, Postgraduate Institute of Medical Sciences, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8750286684 |
| Fax |
|
| Email |
drvandna4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vandna Arora |
| Designation |
Associate Professor |
| Affiliation |
Department of Anaesthesia and critical care, Postgraduate Institute of medical sciences, Rohtak |
| Address |
Department of Anaesthesia and critical care, Postgraduate Institute of Medical Sciences, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8750286684 |
| Fax |
|
| Email |
drvandna4@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Aanand |
| Designation |
Postgraduate Student |
| Affiliation |
Department of Anaesthesia and critical care, Postgraduate Institute of medical sciences, Rohtak |
| Address |
Department of Anaesthesia and critical care, Postgraduate Institute of Medical Sciences, Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9138333436 |
| Fax |
|
| Email |
Aananddangi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesia and critical care postgraduate Institute of medical sciences,Rohtak, Haryana, 124001 |
|
|
Primary Sponsor
|
| Name |
Postgraduate Institute of medical sciences Rohtak |
| Address |
Department of Anaesthesia and critical care postgraduate Institute of medical sciences Rohtak |
| 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 Aanand |
POSTGRADUATE INSTITUTE OF MEDICAL SCIENCES, Rohtak |
Department of Anaesthesia and critical care,Postgraduate Institute of medical sciences, Rohtak
Rohtak
HARYANA |
9138333436
Aananddangi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical research ethics Committee, Pt. BD Sharma pgims, Rohtak |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: PCS||, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
LMA BLOCKBUSTER |
Laryngeal Mask Airway (LMA) Blockbuster, a supraglottic airway device designed for securing the airway during general anesthesia or controlled ventilation.
The LMA Blockbuster features a larger airway tube and a specialized cuff design aimed at optimizing airway seal and minimizing the risk of aspiration.
It is made of medical-grade silicone or latex-free material.
It is used in patients who require controlled ventilation, especially during short procedures or where endotracheal intubation is not required. |
| Comparator Agent |
LMA Proseal |
Laryngeal Mask Airway (LMA) Proseal, is an another supraglottic airway device that provides a higher degree of airway protection compared to standard LMAs.
The LMA Proseal features an additional posterior cuff and a reinforced airway tube for greater airway protection.
It is made from medical-grade silicone or latex-free material and used for securing the airway and facilitating controlled ventilation in patients, offering enhanced protection against aspiration compared to standard LMAs. |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Patients with age group 5 years to 12 years with Mallampatti grade (MPG) 1 or 2 belonging to American society of Anaesthesiologists (ASA) I or II, undergoing elective surgery under general anaesthesia. |
|
| ExclusionCriteria |
| Details |
Difficult airway, BMI more than 95th percentile for the age, History of recent airway infection, Risk or history of Aspiration syndrome, Refusal to consent by parents/guardians will be excluded. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comparison of Time of insertion, ease of insertion, number of attempts, Oropharyngeal leak pressure, Fiberoptic view scoring, Postoperative complications and hemodynamic monitoring after insertion of LMA Blockbuster and LMA Proseal. |
Baseline:
Collect baseline measures (e.g., heart rate, oxygen saturation, blood pressure and end-tidal carbon dioxide).
Immediately after insertion:- Time of insertion, Ease of insertion, number of attempts, Fiberoptic view scoring and Oropharyngeal leak pressure.
Postoperative complications like blood stains on device, sore throat, hoarseness of voice. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Number of attempts, Time of insertion, ease of insertion, fiberoptic view scoring, Oropharyngeal leak pressure, postoperative complications,
hemodynamic monitoring |
Baseline:
Collect baseline measures (e.g., heart rate, oxygen saturation, blood pressure & end-tidal carbon dioxide).
Immediately after insertion:- Time of insertion, Ease of insertion, number of attempts, Fiberoptic view scoring & Oropharyngeal leak pressure.
Postoperative complications like blood stains on device, sore throat, hoarseness of voice. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
Final Enrollment numbers achieved (Total)= "70"
Final Enrollment numbers achieved (India)="70" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
03/02/2025 |
| Date of Study Completion (India) |
15/08/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
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
|
Title: comparison of LMA Blockbuster and LMA Proseal for controlled ventilation in paediatric patients 70 patients (35 in each group) of age group 5 years to 12 years with Mallampatti grade 1 or 2 belonging to American society of Anaesthesiologists (ASA) category I or II, undergoing elective surgery under general anaesthesia. Oropharyngeal leak pressure, time of insertion, number of attempts, ease of insertion, fiberoptic view scoring, Blood/secretion on device will be compared. |