| CTRI Number |
CTRI/2026/02/103838 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
13/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Evaluation Of Stomach Volume In Children One Hour After Intake Of Clear Liquid Using Ultrasound |
|
Scientific Title of Study
|
Preoperative Ultrasound Evaluation Of Gastric Volume After One Hour Of Ingestion Of Clear Liquid In Children : An 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 Virendra Kumar |
| Designation |
Professor |
| Affiliation |
Dr Ram Manohar Lohia Institute Of Medical Sciences, Lucknow |
| Address |
Department of Anaesthesia and CCM , Dr Ram Manohar Lohia Institute Of Medical Sciences, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007232 |
| Fax |
|
| Email |
virendrasankhwar@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Virendra Kumar |
| Designation |
Professor |
| Affiliation |
Dr Ram Manohar Lohia Institute Of Medical Sciences, Lucknow |
| Address |
Department of Anaesthesia and CCM Dr Ram Manohar Lohia Institute Of Medical Sciences Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007232 |
| Fax |
|
| Email |
virendrasankhwar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Virendra Kumar |
| Designation |
Professor |
| Affiliation |
Dr Ram Manohar Lohia Institute Of Medical Sciences, Lucknow |
| Address |
Department of Anaesthesia and CCM , Dr Ram Manohar Lohia Institute Of Medical Sciences, Lucknow
Lucknow
UTTAR PRADESH
226010
India |
| Phone |
8176007232 |
| Fax |
|
| Email |
virendrasankhwar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr. Ram Manohar Lohia Institute Of Medical Sciences, Vibhuti Khand , Gomti Nagar , Lucknow |
|
|
Primary Sponsor
|
| Name |
Dr Ram Manohar Lohia Institute Of Medical Sciences Lucknow |
| Address |
Vibhuti Khand Gomti Nagar Lucknow 226010 |
| 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 Virendra Kumar |
DR. RMLIMS OT COMPLEX AND RPG OT COMPLEX |
Vibhuti Khand Gomti Nagar Lucknow Uttar Pradesh 226010
Lucknow
UTTAR PRADESH |
8176007232
virendrasankhwar@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Dr. RMLIMS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
ASA I OR II
SCHEDULED FOR ELECTIVE SURGERY. |
|
| ExclusionCriteria |
| Details |
History of gastroesophageal reflux or GI disorders .
Emergency Surgeries Patient.
Patient posted for GI Surgeries.
Non cooperative patients or inability to perform ultrasound. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quantitative assessment of gastric volume in mLper kg measured by preoperative gastric ultrasound one hour after ingestion of clear liquids in children |
1 hour after ingestion of clear liquids preoperatively before induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Qualitative grading of gastric contents using Perlas classification at 60 minutes
Proportion of children with gastric volume more than 1.5 mL per kg
Correlation between gastric volume & demographic variables such as age & weight
Incidence of perioperative regurgitation or aspiration |
60 minutes after clear liquid ingestion & prior to induction of anaesthesia |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
04/03/2026 |
| 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 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
|
Preoperative fasting is a cornerstone of paediatric anaesthesia practice primarily aimed at reducing the risk of pulmonary aspiration during general anaesthesia Traditionally children have been required to fast for extended periods before undergoing surgery often for 6 to 8 hours for solids and 2 to 4 hours for clear liquids However recent evidence suggests that such prolonged fasting protocols are not only unnecessary but can also result in adverse effects such as dehydration hypoglycaemia and increased discomfort for young patients As a result numerous paediatric anaesthesia societies including the European Society of Paediatric Anaesthesiology and the American Society of Anaesthesiologists have recommended a reduction in fasting times for clear liquids advocating for a fasting period of at least one hour for clear fluids in children Despite these revised guidelines there remains considerable debate regarding the safety and efficacy of this one hour fasting period The principal concern is whether gastric emptying occurs within one hour ensuring that there is minimal residual gastric content to pose a risk of aspiration during anaesthesia induction Previous studies evaluating gastric emptying in paediatric patients have primarily focused on solid foods and breast milk with less attention given to the clearance of clear liquids such as water juice and clear broths As such clinical evidence supporting the safety of a one hour fast for clear liquids in children is still limited and many clinicians remain cautious about reducing fasting times without stronger empirical backing Ultrasound has been shown to be an effective and reliable method for evaluating gastric emptying in paediatric patients with studies demonstrating its ability to accurately detect both solid and liquid contents The primary advantage of ultrasound over other techniques is its ability to provide immediate feedback on gastric status at the bedside without the need for specialized equipment or invasive procedures Additionally ultrasound offers the potential for repeated assessments to track gastric emptying over time making it particularly valuable in dynamic clinical situations such as preoperative evaluations |