| CTRI Number |
CTRI/2026/04/108193 [Registered on: 12/04/2026] Trial Registered Prospectively |
| Last Modified On: |
11/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
In this study we are assessing the stomach using ultrasound after 8 hours of compulsory fasting before surgery. We are taking two groups, one obese and other diabetic group. |
|
Scientific Title of Study
|
A randomized clinical study for assessing gastric emptying by point-of-care ultrasound in obese and diabetics following
Standard NPO guidelines in patient posted for elective surgery.
|
| Trial Acronym |
Thesis |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr KUNAL KUMAR |
| Designation |
Junior Resident |
| Affiliation |
Subharti Medical College |
| Address |
Department of Anaesthesiology and critical care, 2nd floor, Chhatrapathi Shivaji Subharti Hospital, Subhartipuram.
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7595942877 |
| Fax |
|
| Email |
kunalkrmittal0987@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr PRATIKSHA GOGIA |
| Designation |
Associate Professor |
| Affiliation |
SUBHARTI MEDICAL COLLEGE |
| Address |
Department of Anaesthesiology and critical care, 2nd floor, Chhatrapathi Shivaji Subharti Hospital, Subhartipuram.
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7607011178 |
| Fax |
|
| Email |
pratikshagogia@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr PRATIKSHA GOGIA |
| Designation |
Associate Professor |
| Affiliation |
SUBHARTI MEDICAL COLLEGE |
| Address |
Department of Anaesthesiology and critical care, 2nd floor, Chhatrapathi Shivaji Subharti Hospital, Subhartipuram.
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7607011178 |
| Fax |
|
| Email |
pratikshagogia@gmail.com |
|
|
Source of Monetary or Material Support
|
| Chhatrapathi Shivaji Subharti Hospital, Meerut-250002, India |
|
|
Primary Sponsor
|
| Name |
Chatrapati Shivaji Subharti Hospital |
| Address |
Chhatrapathi Shivaji Subharti Hospital, Subhartipuram, Meerut, India-250002 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Kunal kumar |
Department of Anaesthesiology and critical care, 2nd floor, Chhatrapathi Shivaji Subharti Hospital, Subhartipuram. |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DR KUNAL KUMAR |
Chhatrapati Shivaji Subharti Hospital |
OT complex 1 and 2, department of anaesthesia
Meerut
UTTAR PRADESH |
7595942877
kunalkrmittal0987@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| UNIVERSITY ETHICS COMMITTEE(MEDICAL) |
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 |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
American Society of Anaesthesiologist(ASA) grade 1,2 and 3.
|
|
| ExclusionCriteria |
| Details |
Consent not given for participation in the study. Children under 18 yrs of age.
Emergency surgeries.
Pregnancy.
GI obstruction/history of previous stomach surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assess gastric emptying using POCUS in diabetic obese and diabetic patients after standard fasting. |
Preoperative. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Compare gastric volumes across groups.
Correlate gastric volume with BMI, HbA1c. |
Preoperative. |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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)
|
23/04/2026 |
| 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="2"
Months="0"
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
|
Pulmonary aspiration is a major cause of morbidity and mortality during general anesthesia, and although standard fasting guidelines are used to reduce this risk, they may not be reliable in patients with conditions like diabetes or obesity that affect gastric emptying. Diabetic patients, in particular, are prone to gastroparesis, increasing the likelihood of a full stomach despite adequate fasting. Point-of-care gastric ultrasonography has emerged as a valuable, noninvasive tool to assess gastric contents and volume in real time, helping to better estimate aspiration risk. While obese patients are also considered at higher risk, evidence regarding delayed gastric emptying in this group is inconsistent, and other factors may contribute to their increased anesthetic risk. Therefore, this study aims to use ultrasonography to compare fasting gastric volume between obese diabetic and non-obese diabetic patients undergoing elective surgery. |