| CTRI Number |
CTRI/2026/02/104316 [Registered on: 19/02/2026] Trial Registered Prospectively |
| Last Modified On: |
18/02/2026 |
| 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 two supraglottic airway devices using ultrasound in patients undergoing surgery under general anaesthesia. |
|
Scientific Title of Study
|
Comparation of gastric insufflation between Block buster LMA and Ambu Aura Gain using ultrasonography in adult patients 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 Manju Balal |
| Designation |
Professor |
| Affiliation |
Pt. B.D. Sharma PGIMS Rohtak |
| Address |
Department of Anesthesiology and Critical Care, Pt. B.D. Sharma PGIMS Rohtak
Department of Anesthesiology and Critical Care, Pt. B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
9466234430 |
| Fax |
|
| Email |
manjubala8132@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Savita |
| Designation |
Junior Resident |
| Affiliation |
Pt. B.D. Sharma PGIMS Rohtak |
| Address |
Department of Anesthesiology and Critical Care, Pt. B.D. Sharma PGIMS Rohtak
Department of Anesthesiology and Critical Care, Pt. B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8570894360 |
| Fax |
|
| Email |
savitamalhan123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Savita |
| Designation |
Junior Resident |
| Affiliation |
Pt. B.D. Sharma PGIMS Rohtak |
| Address |
Department of Anesthesiology and Critical Care, Pt. B.D. Sharma PGIMS Rohtak
Department of Anesthesiology and Critical Care, Pt. B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA
124001
India |
| Phone |
8570894360 |
| Fax |
|
| Email |
savitamalhan123@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pt. B.D. Sharma PGIMS Rohtak, HARYANA 124001 |
|
|
Primary Sponsor
|
| Name |
Pt. B.D. Sharma PGIMS Rohtak |
| Address |
Department of Anesthesiology and Critical Care, Pt. B.D. Sharma PGIMS 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 Savita |
Pt. B.D. Sharma PGIMS Rohtak |
Department of Anesthesiology and Critical Care,Modular OT Complex, Pt. B.D. Sharma PGIMS Rohtak
Rohtak
HARYANA |
8570894360
savitamalhan123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Biomedical Research Ethical Committee |
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 |
| Comparator Agent |
AMBU AURA GAIN |
AMBU AURA GAIN is inserted and Gastric insufflation is assessed and compared by measuring antral cross section area and gastric volume at the end of surgery by using ultra sono graphy. Baseline gastric antral cross sectional area (Ao) will be measured using 2-5MHZ curvilinear probe placed over epigastrium in supine position with the left lobe of the liver,aorta,and inferior vena ava,as the landmark. The antrum will be located between left of liver anteriorly and the pancreas posteriorly in a saggital and parasaggital scanning plane in the epigastrium and probe position will be marked for susequent readings. After face mask ventilation, measurement of antral cross section area(A1) will be done . Appropriate size of AMBU AURA GAIN will be selected according to weight of the patient. Airway device will be checked and lubricated with water based gel before use. At he end of surgery 3rd reading of gastric CSA(A2) will be recorded using ultrasonography. After removal of AMBU AURA GAIN. Postoperative complications will also be noted. |
| Intervention |
Blockbuster LMA |
Blockbuster LMA is inserted and Gastric insufflation is assessed and compared by measuring antral cross section area and gastric volume at the end of surgery by using ultra sono graphy. Baseline gastric antral cross sectional area (Ao) will be measured using 2-5MHZ curvilinear probe placed over epigastrium in supine position with the left lobe of the liver,aorta,and inferior vena ava,as the landmark. The antrum will be located between left of liver anteriorly and the pancreas posteriorly in a saggital and parasaggital scanning plane in the epigastrium and probe position will be marked for susequent readings. After face mask ventilation, measurement of antral cross section area(A1) will be done . Appropriate size of blockbuster LMA will be selected according to weight of the patient. Airway device will be checked and lubricated with water based gel before use. At he end of surgery 3rd reading of gastric CSA(A2) will be recorded using ultrasonography. After removal of blockbuster LMA. Postoperative complications will also be noted. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Seventy patients of either sex, aged between 18-60 years belonging to ASA physical status I and II scheduled for elective surgery upto 2 hours under general anesthesia where placement of supraglottic airway device is indicated will be enrolled for the study |
|
| ExclusionCriteria |
| Details |
upper gasroesophageal reflux disorder, mouth opening less than 2 centimeters, pregnancy, BMI more than 30kg/m2, refusal to participate |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess and compare the gastric insufflation between Blockbuster LMA and Ambu aura gain Supraglottic Airway Devices (SADs) by measuring the antral CSA and gastric volume at the end of surgery by using ultrasonography |
Antral cross section area ( CSA) will be measured before facemask ventillation CSA A0, after facemask ventillation before LMA insertion CSA A1 and at the end of surgery CSA A2 with in 2 hours. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To measure & compare the two devices in terms of Oropharyngeal leak pressure , Peak airway pressure, Post operative device related complications. |
oropharyngeal leak pressure & peak airway pressure will be measured & compared after either of the LMA insertion after induction (base line) & at the end of surgery with in 2 hours. |
|
|
Target Sample Size
|
Total Sample Size="70"
Sample Size from India="70"
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)
|
05/03/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
05/03/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="2" |
|
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
|
This study is to compare SADs Block Buster LMA
and Ambu aura gain in terms of Gastric insufflation during general anesthesia in adult patients
undergoing elective surgery by measuring the antral CSA and gastric volume at the end of
surgery by using ultrasonography in 18 - 60 years, ASA 1 and 2 patients scheduled for elective surgery upto 2 hours under general anesthesia. Oropharyngeal leak pressure (OPLP), Peak airway pressure (PAP), Post operative device related
complications will be assesed and compared for these two SADs. Data will be compiled and appropriate statistical test will be used to analyse the result. |