| CTRI Number |
CTRI/2025/05/087184 [Registered on: 20/05/2025] Trial Registered Prospectively |
| Last Modified On: |
16/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of 2 supraglottic airway devices,Ambu AuraGain Vs BlockBuster Laryngeal Mask, in laproscopic surgeries in children |
|
Scientific Title of Study
|
A randomized coparativesuty of AmbuAuraGain Vs BlockBuster Laryngeal Mask for controlled ventilation in paediatric laparoscopic surgeries under general anaesthesia in Department of Anaesthesia, S.M.S Medical College and Attached hospitals, Jaipur. |
| 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. Gayatri Appat B |
| Designation |
Junior Resident, MD Anaesthesiology |
| Affiliation |
JK LONE HOSPITAL, UNDER SAWAI MAN SINGH MEDICAL COLLEGE AND HOSPITAL |
| Address |
Department of Anaesthesiology, Second floor, Dhanwantari, S.M.S medical College and Attached hospitals, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9446172472 |
| Fax |
|
| Email |
gayatriappat@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Neelam Dogra |
| Designation |
Senior Professor |
| Affiliation |
JK Lone Hospital, Under S.M.S Medical College and Attached Hospitals |
| Address |
Department of Anaesthesiology, second floor, Dhanwantari building, S.M.S Medical College and Attached hospitals, Jaipur, Rajasthan
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928709289 |
| Fax |
|
| Email |
neelam_dogra24@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Neelam Dogra |
| Designation |
Senior Professor |
| Affiliation |
JK Lone Hospital, Under S.M.S Medical College and Attached Hospitals |
| Address |
Department of Anaesthesiology, second floor, Dhanwantri Building, S.M.S Medical college and Attached hospitals, Jaipur
Jaipur
RAJASTHAN
302004
India |
| Phone |
9928709289 |
| Fax |
|
| Email |
neelam_dogra24@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Sawai Man Singh Medical College and Attached Hospitals, Jaipur, Rajasthan, India. 302004 |
|
|
Primary Sponsor
|
| Name |
SMs Medical College and Attached Hospitals |
| Address |
Department of Anaesthesiology, second floor, Dhanwantri Building, S.M.S Medical college and Attached hospitals, Jaipur, Rajasthan, India. 302004 |
| 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 Gayatri Appat B |
JK lone Hospital |
Pediatrics OT, JK Lone Hospital, under Sawai Man Singh Medical College and Attached Hospitals, Jaipur, Rajasthan
Jaipur
RAJASTHAN |
09446172472
gayatriappat@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| THE OFFICE OF ETHICAL COMMITTEE, SMS MEDICAL COLLEGE AND HOSPITAL, JAIPUR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 4||Measurement and Monitoring, (2) ICD-10 Condition: K36||Other appendicitis, (3) ICD-10 Condition: K80||Cholelithiasis, (4) ICD-10 Condition: Q53||Undescended and ectopic testicle, (5) ICD-10 Condition: N130||Hydronephrosis with ureteropelvicjunction obstruction, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Comparing the ventilatory effectiveness of two supraglottic devices; Ambu AuraGain and BlockBuster |
After induction of anaesthesia, the ventilatory parameters and the oropharyngeal leak pressure after insertion of LMA and 10 mins after pneumoperitoneum creation are checked. The LMAs are selected randomly using sequentially numbered sealed opaque envelopes. All these parameters and the post operaitive complications are checked in both the LMAs |
| Intervention |
Insertion of BlockBuster |
After receiving and identifying the patient, using sealed envelope technique, the type of Supraglottic device is selected. After induction, an appropriate size of BlocBuster is selected according to the weight of the patient and is inserted. The number of attempts, the time of insertion, the fibreoptic grading of glottis, oroharyngeal leak pressure after insertion and 10 mins after creation of pneumoperitoneum, the post operative complications are noted. |
| Intervention |
Insertion of Ambu AuraGain |
After receiving and identifying the patient, using sealed envelope technique, the type of Supraglottic device is selected. After induction, an appropriate size of Ambu AuraGain is selected according to the weight of the patient and is inserted. The number of attempts, the time of insertion, the fibreoptic grading of glottis, oroharyngeal leak pressure after insertion and 10 mins after creation of pneumoperitoneum, the post operative complications are noted. |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
1 ASA physical statuses 1 and 2
2 Undergoing elective laparoscopic surgeries.
3 Informed written consent from parent/guardian for the study.
|
|
| ExclusionCriteria |
| Details |
1. Syndromic children with difficult airway, intraoral pathology.
2. Patients who had recent respiratory tract infections.
3. Patients with risk of aspiration.
4. Patient should not be part of any other study.
5) Non cooperative patient
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.The difference in Oropharyngeal Leak Pressure between the two supraglottic devices immediately after insertion and 10 minutes after pneumoperitoneum creation.
2.The difference in ventilatory parameters (tidal volume, respiratory rate, leak and peak airway pressure) between the two supraglottic devices. |
1. Oropharyngeal leak pressure is checked immediately and 10mins after pneumoperitoneum creation
2. Ventilatory parameters: Immediately after insertion of LMA, after patient positioning, after preumoperitoneum creation, 10mins after preumoperitoneum creation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To determine the differences in insertion characteristics between the two supraglottic devices in terms of time taken for insertion of device, number of attempts taken & ease of insertion.
2.To determine the difference in fiberoptic grading of glottis in both the groups.
3.To determine the difference in gastric tube insertion
4.To determine the difference in percentage of complications (laryngospasm, bronchospasm, blood staining on the back of the device, dysphagia & dysphonia) in both the groups. |
I. Differences in insertion characteristics, fibreoptic grading of glottis, gastric tube insertion are checked immediately after LMA insertion
2. Postoperative complications are checked after the surgery. Dysphagia checked 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="64"
Sample Size from India="64"
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 2 |
|
Date of First Enrollment (India)
|
28/05/2025 |
| 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="0"
Months="2"
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
|
Supraglottic airway devices are an established
part of routine and emergency pediatric airway management, including use in
difficult airways and neonatal resuscitation. Since their introduction into
medical practice, supraglottic airway devices have proven safe and efficient in
various settings. The BlockBuster laryngeal mask (LM) has shown to
have higher oropharyngeal leak pressure in adults ) and children. Ambu AuraGain has shown its
efficacy in pediatric anesthesia compared with other second-generation
supraglottic airway devices. The comparison
studies between the BlockBuster LM and Ambu AuraGain are lacking in pediatric
laparoscopic surgeries hence this study is proposed to compare the ventilatory effectiveness
of the above mentioned two supraglottic devices in controlled ventilation
during pediatric laparoscopic surgeries.
|