| CTRI Number |
CTRI/2025/05/087102 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
18/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare oropharyngeal leak pressure of Blockbuster and Proseal
Laryngeal Mask Airway in paediatric
patients undergoing surgery
under General Anaesthesia |
|
Scientific Title of Study
|
Comparison of Oropharyngeal leak
pressure of Blockbuster vs Proseal
Laryngeal Mask Airway in pediatric
patients undergoing elective surgery
under General Anaesthesia |
| 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 Gurkaran Kaur Sidhu |
| Designation |
Professor |
| Affiliation |
GGSMCH, Faridkot |
| Address |
Department of Anaesthesiology, GGSMCH, Faridkot, Punjab
Faridkot
PUNJAB
151203
India |
| Phone |
9876766522 |
| Fax |
|
| Email |
sugarsidhu2007@outlook.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gurkaran Kaur Sidhu |
| Designation |
Professor |
| Affiliation |
GGSMCH, Faridkot |
| Address |
Department of Anaesthesiology, GGSMCH, Faridkot, Punjab
Faridkot
PUNJAB
151203
India |
| Phone |
9876766522 |
| Fax |
|
| Email |
sugarsidhu2007@outlook.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gurkaran Kaur Sidhu |
| Designation |
Professor |
| Affiliation |
GGSMCH, Faridkot |
| Address |
Department of Anaesthesiology, GGSMCH, Faridkot, Punjab
Faridkot
PUNJAB
151203
India |
| Phone |
9876766522 |
| Fax |
|
| Email |
sugarsidhu2007@outlook.com |
|
|
Source of Monetary or Material Support
|
| Department of Anaesthesiology, GGSMCH, Faridkot, Punjab, India, 151203 |
|
|
Primary Sponsor
|
| Name |
Dr Gurkaran Kaur Sidhu |
| Address |
Department of Anaesthesiology, GGSMCH, Faridkot, Punjab, India, 151203 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Ashish Chhabra |
Div of Pediatric Surgery, Department of Surgery, GGSMCH, Faridkot |
| Dr Seema Jindal |
Department of Anaesthesiology, GGSMCH, Faridkot |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Pranati Garg |
Guru Gobind Singh Medical College and Hospital |
Department of Anaesthesiology, GGSMCH, Faridkot
Faridkot
PUNJAB |
08168435038
pranatigarg29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee of GGSMCH, Faridkot |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K35-K38||Diseases of appendix, (2) ICD-10 Condition: N43||Hydrocele and spermatocele, (3) ICD-10 Condition: K40||Inguinal hernia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Blockbuster Laryngeal Mask Airway |
The patient will be placed in supine position. Head will be tilted backward with a
pillow. Fixed band will be placed to the back of the neck. Patient’s mouth will be
opened with the left hand and the blockbuster LMA will be placed along the mouth
axis with the right hand. When resistance will be encountered, we will gently push
the patient’s forehead with the left hand to tilt the head and then we will push the
LMA in left-right rotating motion with the right hand. Then we will
inflate the cuff with a syringe to about 30 cmH2O. Breathing circuit will then be
connected and positive pressure ventilation will be given. |
| Comparator Agent |
Proseal Laryngeal Mask Airway |
The patient will be positioned in sniffing posture. The cuff of Proseal LMA will be
deflated into a wedge shape. The cricoid pressure may be briefly released to allow
the Proseal LMA to pass. The metal introducer tip will be inserted into the strap at
the top of the cuff. On either side of the introducer, airway and the drainage tubes
will be folded around the matching slots. On the posterior tip lubricant will be applied
then pressed against the hard palate and maneuvered to spread the lubricant along
the hard palate. Keeping the introducer close to the chin, ensuring that the cuff will
not fold over, the introducer will be swung inward in a smooth circular movement.
Then jaw will be pushed downward with the middle finger, but not too wide open
because this maneuver may cause the tongue and the epiglottis to drop downward
and block the passage. The Proseal LMA will be advanced until resistance is felt.After placing the Proseal LMA, an adequate cuff pressure of upto 60cm H2O would be given. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
1. Pediatric patients of age 2-10 years, weighing 10-30 kg, after having valid
informed and written consent from parents/ Guardians
2. American Society of Anaesthesiologist Grade I and II.
3. Posted for elective surgeries under general anaesthesia |
|
| ExclusionCriteria |
| Details |
1. Patients having high risk of aspiration.
2. Patients having recent (last 10 days) upper respiratory tract infection. (URTI)
3. Patients having restricted mouth opening or anticipated difficult airway.
4. Any facial, laryngeal and pharyngeal anatomy problem. |
|
|
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 |
To assess the oropharyngeal leak pressure with Blockbuster LMA in pediatric patients undergoing elective surgery under general anaesthesia.
To assess the oropharyngeal leak pressure with Proseal
LMA in pediatric
patients undergoing elective surgery under general anaesthesia. |
Till 1 minute after securing the airway |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare the oropharyngeal leak pressure of LMA Blockbuster with LMA
Proseal in pediatric patients undergoing elective surgery under general
anaesthesia. |
Till 1 minute after securing the airway |
To compare the oropharyngeal leak percentage of LMA Blockbuster with LMA
Proseal in pediatric patients undergoing elective surgery under general
anaesthesia. |
5 mins post device insertion |
To compare the Peak Inspiratory Pressure of LMA Blockbuster with LMA
Proseal in pediatric patients undergoing elective surgery under general anaesthesia. |
Just before extubation |
To compare the Insertion Time of LMA Blockbuster with LMA
Proseal in pediatric patients undergoing elective surgery under general anaesthesia. |
Just after device insertion |
To compare the Number of attempts for LMA Blockbuster with LMA
Proseal in pediatric patients undergoing elective surgery under general anaesthesia. |
Just after device insertion |
To compare the Ease of Insertion of LMA Blockbuster with LMA
Proseal in pediatric patients undergoing elective surgery under general anaesthesia. |
Just after device insertion |
To compare the hemodynamic parameters of LMA Blockbuster with LMA
Proseal in pediatric patients undergoing elective surgery under general anaesthesia. |
Till the end of surgery |
To compare the Post of Complications of LMA Blockbuster with LMA
Proseal in pediatric patients undergoing elective surgery under general anaesthesia. |
Just after extubation |
|
|
Target Sample Size
|
Total Sample Size="34"
Sample Size from India="34"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
31/05/2025 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Airway management is a challenging task in children and a variety of
devices have been developed precisely for this purpose. Supraglottic airway devices
[SAD] are standard equipment in airway management. They play an important role
between face mask and tracheal tube in terms of airway device position and degree
of invasiveness in patient’s airway. These supraglottic airway devices are used to
ventilate the patient above the level of vocal cords. The Proseal mask and the
Blockbuster LMA are new generation SAD with an incorporated gastric channel. |