| CTRI Number |
CTRI/2023/04/051881 [Registered on: 24/04/2023] Trial Registered Prospectively |
| Last Modified On: |
21/04/2023 |
| 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
|
COMPARING BLOCKBUSTER LMA WITH SUPREME LMA AIRWAY IN CHILDREN |
|
Scientific Title of Study
|
COMPARISON OF BLOCKBUSTER LARYNGEAL MASK AIRWAY WITH SUPREME LARYNGEAL MASK AIRWAY IN PAEDIATRIC PATIENTS: A PROSPECTIVE RANDOMIZED CLINICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
SAWDAH SHAHID HABIB |
| Designation |
POST GRADUATE RESIDENT, FIRST YEAR |
| Affiliation |
HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE |
| Address |
OPERATION THEATRE, 8TH FLOOR, ANESTHESIA DEPARTMENT, HAMDARD NAGAR DELHI 110062 SOUTH DELHI
HAMDARD INSTITUTE OF MEDICAL SCIENCES, HAMDARD NAGAR, Delhi,110062
South
DELHI
110062
India |
| Phone |
9354342076 |
| Fax |
|
| Email |
ssh.sawdah@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KHARAT MOHD BATT |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT, DEPARTMENT OF ANAESTHESIA |
| Affiliation |
HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESERCH |
| Address |
OPERATION THEATRE, 8TH FLOOR, ANESTHESIA DEPARTMENT, HAMDARD NAGAR DELHI 110062 SOUTH DELHI
South
DELHI
110062
India |
| Phone |
9622457554 |
| Fax |
|
| Email |
hod.anaesthesia@himsr.co.in |
|
Details of Contact Person
Public Query
|
| Name |
DR KHARAT MOHD BATT |
| Designation |
PROFESSOR AND HEAD OF DEPARTMENT, DEPARTMENT OF ANAESTHESIA |
| Affiliation |
HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESERCH |
| Address |
OPERATION THEATRE, 8TH FLOOR, ANESTHESIA DEPARTMENT, HAMDARD NAGAR DELHI 110062 SOUTH DELHI
South
DELHI
110062
India |
| Phone |
9622457554 |
| Fax |
|
| Email |
hod.anaesthesia@himsr.co.in |
|
|
Source of Monetary or Material Support
|
| HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESERCH, DELHI |
|
|
Primary Sponsor
|
| Name |
DR SAWDAH |
| Address |
BLOCK B, HAMDARD NAGAR, GURU RAVIDAS MARG, HAMDARD NAGAR, NEW DELHI, DELHI 110062 |
| 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 SAWDAH SHAHID HABIB |
HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESERCH, HAMDARD NAGAR, DELHI 110062 |
PERIOPERATIVE AREA
OPERATING ROOM NO. 1
OPERATION THEATRE complex, 8TH FLOOR, DEPARTMENT OF ANAESTHESIA, HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESERCH. HAMDARD NAGAR
South
DELHI |
9354342076
ssh.sawdah@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITEE HAMDARD INSTITUTE OF MEDICAL SCIENCES AND RESERCH AND ASSOCIATED HAH CENTENARY HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
PAEDIATRIC AGE GROUP POSTED FOR SHORT SURGICAL PROCEDURES |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
GROUP A - BLOCKBUSTER LMA SIXE 2.0 |
DEVICE TO BE DEFLATED AND INSERTED WITH THE INTRACUFF PRESSURE STANDARDIZED AND MAINTAINED AT 60CM H2O USING A CUFF MANOMETER
Duration: 4 minutes |
| Comparator Agent |
GROUP B- SUPREME LMA SIXE 2.0 |
DEVICE TO BE DEFLATED AND INSERTED WITH THE INTRACUFF PRESSURE TO BE STANDARDIZED AND MAINTAINED AT 60CM H20 USING A CUFF MANOMETER
Duration : 4 minutes |
|
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Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
6.00 Year(s) |
| Gender |
Both |
| Details |
WEIGHT 10KGS - 20 KGS
AMERICAN SOCIETY OF ANAESTHESIOLOGY (ASA) PHYSICAL STATUS 1 -2.
SCHEDULED FOR ELECTIVE SURGERY UNDER GENERAL ANAESTHESIA REQUIRING SUPRAGLOTTIC DEVICE INSERTION |
|
| ExclusionCriteria |
| Details |
PARENTS OR LEGAL GUARDIAN OF THE PATIENT NOT CONSENTING.
PATIENTS WITH LARYNGEAL OR PHARYNGEAL PATHOLOGY.
KNOWN OR ANTICIPATED DIFFICULT AIRWAY
ACTIVE RESPIRATORY TRACT INFECTION ON THE DAY OF SURGERY.
RISK OF ASPIRATION. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the oropharyngeal leak pressure between the two devices. |
5 minutes
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
• To compare the time taken for insertion of the devices.
• To compare the number of attempts taken for insertion
• To compare the ease of placement of the device
• To compare the alignment of the device with the larynx.
• To compare the ease of gastric tube insertion between two devices.
|
2 minutes |
|
|
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)
|
25/04/2023 |
| 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
|
NONE |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Airway management is an essential skill in Paediatric anaesthesia. A challenging airway, inadequately prepared for, or sub-optimally managed, can be a determining factor in morbidity and mortality in paediatrics. The Laryngeal Mask Airway (LMA) and other supraglottic airway devices has led to important changes in airway management in routine as well as emergency procedures.
Paediatric age group poses a variety of facial, oral and pharyngeal anatomical variations and all of this can contribute to difficulty in airway management. Apart from this, regional anaesthesia cannot be solely done in paediatric age group due to incorporation by the patient and henceforth Supraglottic airway devices serves primary as well as a rescue device and as a conduit for endotracheal intubation when managing patients with a difficult airway.
There are several advantages of using SGAs over endotracheal tube intubation which includes quicker and easier placement, reduction in neuromuscular blocking drug usage, anaesthetic requirement for device placement, emergence coughing, and laryngeal and subglottic trauma, and preservation of laryngeal competence and mucociliary function The LMA SUPREME is a single use device available in all sizes. It has a rigid curved airway tube, a drain tube positioned within the centre of the airway tube and a larger cuff made of polyvinyl chloride. Its rigid and curved design allows for placement without the need for digital guidance or assistance with other equipment, a potential benefit for inexperienced users. Also it is more suitable when the option for gastric access is needed in children.
A newer LMA called Tourens BlockBuster® LMA invented in 2012 for adults has been gaining popularity to provide increased safety and quality of anaesthesia. It is advantageous in providing ventilation and a channel for intubation.
Currently there are no studies regarding the use of LMA BLOCKBUSTER in paediatric age group. and henceforth in this prospective study we shall be comparing the performance of blockbuster LMA with supreme LMA in paediatric patients.
In this we hypothesise that the OLP of LMA BLOCKBUSTER is better than OLP of LMA SUPREME
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