| CTRI Number |
CTRI/2025/08/092657 [Registered on: 08/08/2025] Trial Registered Prospectively |
| Last Modified On: |
07/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
effect of ultrasound guided compression of esophagus to check stomach inflation in children during face mask ventilation |
|
Scientific Title of Study
|
Effect of ultrasound-guided esophageal
compression and gastric insufflation during face
mask ventilation in pediatric 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 |
shubham |
| Designation |
Post Graduate Student |
| Affiliation |
ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi |
| Address |
Room no.301 3rd floor Department Of Anaesthesia ABVIMS AND
DR. RML HOSPITAL Central DELHI 110001 India
New Delhi
DELHI
110001
India
Central
DELHI
110001
India |
| Phone |
8708684360 |
| Fax |
|
| Email |
shubhammdical@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aanchal Kakkar |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi |
| Address |
Room no.301 3rd floor Department Of Anaesthesia ABVIMS AND
DR. RML HOSPITAL Central DELHI 110001 India
New Delhi
DELHI
110001
India
Central
DELHI
110001
India |
| Phone |
9899368080 |
| Fax |
|
| Email |
kakkaraanchal2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aanchal Kakkar |
| Designation |
Professor |
| Affiliation |
ABVIMS and Dr. Ram Manohar Lohia Hospital, New Delhi |
| Address |
Room no.301 3rd floor Department Of Anaesthesia ABVIMS AND
DR. RML HOSPITAL Central DELHI 110001 India
New Delhi
DELHI
110001
India
DELHI
110001
India |
| Phone |
9899368080 |
| Fax |
|
| Email |
kakkaraanchal2@gmail.com |
|
|
Source of Monetary or Material Support
|
| ABVIMS and Dr.Ram Manohar Lohia Hospital, Babe Kharak Singh Marg, Near Gurudwara Bangla Sahib ‚Connaught Place, New Delhi
110001 New Delhi |
|
|
Primary Sponsor
|
| Name |
Atal Bihari Vajpayee Institute of Medical Sciences and Dr. Ram Manohar Lohia Hospital |
| Address |
Department of Anaesthesia ABVIMS and Dr. RML Hospital New Delhi 110001 |
| 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 Aanchal Kakkar |
ABVIMS and Dr. Ram Manohar Lohia Hospital |
Room no.301 3rd floor
Department Of
Anaesthesia ABVIMS
AND DR. RML
HOSPITAL Central
DELHI 110001 India
North
DELHI
Central
DELHI |
9899368080
kakkaraanchal2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee ABVIMS and Dr. RML Hospital, New Delhi |
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 |
no esophageal compression |
measurement of gastric antrum in pediatric patients during face mask ventilation undergoing elective surgery |
| Comparator Agent |
USG guided esophageal compression |
Ultrasound-guided measurement of the gastric antrum with concurrent esophageal compression during face mask ventilation in pediatric patients undergoing elective surgery (3-minute intervention) |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
8.00 Year(s) |
| Gender |
Both |
| Details |
All ASA I and Il pediatric patients of age group 2 to 8 years, scheduled for elective
surgery under general anesthesia will be enrolled for the study. |
|
| ExclusionCriteria |
| Details |
1. Patient with increased risk of aspiration
2. Patients diagnosed with delayed gastric emptying time
3. Difficulty in visualization of gastric antrum with ultrasound. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Gastric antrum area before and after face mask ventilation. |
at baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Air insufflation into the esophagus.
2. Difference in the Percentage of Glottic Opening (POGO) score during laryngoscopy with
esophageal compression |
at baseline |
|
|
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)
|
19/08/2025 |
| 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="5"
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
|
This study involves ultrasound-guided measurement of gastric antral area (GAA) before and after face mask ventilation in pediatric patients. Patients will be randomly divided into two groups. Group 1 will undergo esophageal compression during face mask ventilation, where the esophagus will be visualized using a linear probe and compressed to prevent insufflation. Group 2 will receive standard ventilation without any esophageal compression. GAA will be measured in supine position using curvilinear ultrasound before and after the procedure. The cross-sectional area of the gastric antrum will be calculated using standard diameters. Esophageal insufflation and ventilation parameters will be recorded. POGO score will be assessed after intubation by a different anesthesiologist. |