| CTRI Number |
CTRI/2025/12/098837 [Registered on: 10/12/2025] Trial Registered Prospectively |
| Last Modified On: |
10/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To study the volume of water in stomach after drinking at 1 and 2 hour using ultrasound in pediatric patients. |
|
Scientific Title of Study
|
Serial ultrasound assessment of gastric volume in pediatric patients at one and two hours after water intake: a prospective observational study. |
| 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 Arushi Gautam |
| Designation |
Post graduate junior resident |
| Affiliation |
AIIMS Raipur |
| Address |
Seminar room OT complex B block department of anaesthesiology All India institute of medical sciences G E road Tatibandh Raipur Chhattisgarh 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
8588030365 |
| Fax |
|
| Email |
arushi.gautam18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mayank Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Raipur |
| Address |
Faculty room no 3 A block department of anaesthesiology All India institute of medical sciences GE road Tatibandh Raipur Chhattisgarh 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
9971760416 |
| Fax |
|
| Email |
mayanksonupmch@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mayank Kumar |
| Designation |
Additional Professor |
| Affiliation |
AIIMS Raipur |
| Address |
Faculty room no 3 A block department of anaesthesiology All India institute of medical sciences GE road Tatibandh Raipur Chhattisgarh 492099
Raipur
CHHATTISGARH
492099
India |
| Phone |
9971760416 |
| Fax |
|
| Email |
mayanksonupmch@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AII India institute of medical sciences |
| Address |
Tatibandh , Raipur , Chhattisgarh 492099 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Arushi Gautam |
All india institute of medical sciences |
Pre operative area , B Block OT complex , Fourth floor , AIIMS , GE Road , Tatibandh, Raipur Chhattisgarh 492099
Raipur
CHHATTISGARH |
8588030365
arushi.gautam18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute of ethics committee, AIIMS Raipur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B||Imaging, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
10.00 Year(s) |
| Gender |
Both |
| Details |
· Children aged 3 - 10 years
· ASA physical status I or II
· Scheduled for elective surgery under general anesthesia
· Consent from parent or legal guardian
|
|
| ExclusionCriteria |
| Details |
· Known gastrointestinal pathology (GERD, pyloric stenosis, delayed gastric emptying)
· Diabetes mellitus or other metabolic disorders
· Emergency surgeries
· Refusal of consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Difference in mean gastric volume (mL/kg) between the 1 hour and 2 hour ultrasound assessments in the same pediatric patients. |
One hour and two hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in Perlas gastric volume grading between 1 and 2 hour post water intake |
1 and 2 hour |
Proportion of children with an at-risk stomach at each time point defined as
Gastric volume more than 1.5 mL/kg or
Perlas Grade 2 (fluid visible in both supine and RLD positions).
|
1 and 2 hour |
| Correlation between antral CSA and calculated gastric volume at each time point. |
1 and 2 hour |
| Distribution of gastric volume types (empty, water, solid) at both intervals. |
1 and 2 hour |
| Influence of age, weight, and gender on gastric emptying and gastric volume |
1 and 2 hour |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
25/12/2025 |
| 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
|
The PG thesis synopsis for MD Anaesthesia titled “Serial Ultrasound Assessment of Gastric Volume via Pediatric Patients at One and Two Hours after Water Intake: A Prospective Observational Study” aims to investigate gastric volume and pre induction changes in children at one and two hours following water ingestion, using bedside ultrasound. The study will be conducted in the pediatric age group of 3-10years. Children posted for general anaesthesia for elective surgery under general anaesthesia will be included after obtaining informed consent from parents/guardians.Participants will recieve water at 3ml/kg up to maximum of 200 ml .Patients will be assessed at 0 hour (baseline), 1 hour, and 2 hours post water ingestion in both supine and right lateral decubitus position . Gastric ultrasound will be performed to measure antral cross sectional area and gastric volume using validated models (Perla’s grading) . A stomach is classified high risk if gastric volume is more than 1.5ml/kg and/or Perla’s grade 2. The study is important in evaluating fasting guidelines in children, since new evidence supports clear fluid intake up to one hour before anaesthesia. This study aims to contribute meaningful, evidence-based data in the Indian pediatric population to support safe, comfortable fasting protocols.
|