| CTRI Number |
CTRI/2025/09/094794 [Registered on: 15/09/2025] Trial Registered Prospectively |
| Last Modified On: |
12/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Bedside Ultrasound Of Stomach To See How Empty Stomach Is Before Elective Surgery |
|
Scientific Title of Study
|
Role Of Point of Care Gastric Ultrasound In Assessment Of Gastric Emptying In Individuals Scheduled For Elective Procedure |
| 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 Jyoti Panda |
| Designation |
Anaesthesia Resident |
| Affiliation |
Aster CMI Hospital |
| Address |
Department Of Anaesthesiology Aster CMI Hospital Door No 43/2, New Airport Road, NH 7 Sahakara Nagar, Hebbal Bengaluru-560092
Bangalore
KARNATAKA
560092
India |
| Phone |
9481354224 |
| Fax |
|
| Email |
jyotipaanda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Gaurang J Kothari |
| Designation |
Consultant |
| Affiliation |
Aster CMI Hospital |
| Address |
Department Of Anaesthesiology Aster CMI Hospital Door No 43/2, New Airport Road, NH 7 Sahakara Nagar, Hebbal Bengaluru-560092
Bangalore
KARNATAKA
560092
India |
| Phone |
8105885778 |
| Fax |
|
| Email |
gaurangkothari29@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR Gaurang J Kothari |
| Designation |
Consultant |
| Affiliation |
Aster CMI Hospital |
| Address |
Department Of Anaesthesiology Aster CMI Hospital Door No 43/2, New Airport Road, NH 7 Sahakara Nagar, Hebbal Bengaluru-560092
Bangalore
KARNATAKA
560092
India |
| Phone |
8105885778 |
| Fax |
|
| Email |
gaurangkothari29@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aster CMI Hospital Door No 43/2, New Airport Road, NH 7 Sahakara Nagar, Hebbal Bengaluru-560092
|
|
|
Primary Sponsor
|
| Name |
Aster CMI Hospital |
| Address |
Aster CMI Hospital Door No 43/2, New Airport Road, NH 7 Sahakara Nagar, Hebbal Bengaluru-560092
|
| 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 Jyoti Panda |
Aster CMI Hospital |
Aster CMI Hospital Door No 43/2, New Airport Road, NH 7 Sahakara Nagar, Hebbal Bengaluru-560092
Bangalore
KARNATAKA |
9481354224
jyotipaanda@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ASTER IEC |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Diabetes mellitus,chronic kidney disease, Obesity,Medication like proton pump inhibitors ,Glucagon like peptide-1 receptor agonists,anticholinergics anti-Parkinsonian agents calcium channel blockers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged above 20 years scheduled for elective surgery,
with an expected fasting period of at least 6 hours for solids and 2 hours for clear fluids.
|
|
| ExclusionCriteria |
| Details |
Previous gastric surgery (e.g., gastric bypass, gastrectomy),Pregnancy,Pediatric group,Emergency surgeries,Patients who are critically ill or require immediate airway intervention,
Inability to perform gastric ultrasound such as, poor sonographic window,Refusal to participate.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To determine the prevalence of delayed gastric emptying using point of care gastric ultrasound in patients scheduled for elective procedures .
|
16 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To assess gastric volume and content type (empty, fluid, thick fluid or solid) using Point of Care Gastric Ultrasound (POCUS) in individuals posted for elective procedure and to evaluate the relationship ,if any between ultrasound findings and patient-specific factors such as BMI, HBA1C, eGFR, comorbidities (like diabetes, GERD), history of drug use like proton pump inhibitors, anti-Parkinsonian drugs, calcium channel blockers, Glucagon like peptide-1 agonists etc
|
16 months |
|
|
Target Sample Size
|
Total Sample Size="1200"
Sample Size from India="1200"
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)
|
11/10/2025 |
| 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="4"
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
|
Eligible participants will include adults aged over 20 years, regardless of sex, who are scheduled for elective procedure.Baseline demographic and clinical parameters will be recorded, including age, sex, height, weight, and BMI. Relevant comorbidities such as diabetes mellitus, chronic kidney disease (CKD), Parkinson’s disease, and any gastrointestinal disorders will be noted. Medication histories will be collected, with specific attention to drugs that delay gastric emptying, including proton pump inhibitors (PPIs),Glucagon like peptide-1 (GLP-1 )receptor agonists, opioids, anticholinergics, and anti-Parkinsonian agents ,calcium channel blockers Laboratory data such as HbA1c (within the previous 3 months) and serum creatinine will be noted if applicable. Point-of-care gastric ultrasound will be performed in supine and right lateral decubitus positions,content type whether solid,clear fluid or empty will be noted and gastric volume will be estimated using perlas formula if content is clear liquid. Perlas formula GV (ml) = 27.0 + 14.6 × CSA (cm²) – 1.28 × age (years) Data will be analysed to assess any relationship if any between patient specific factors and gastric sonographic findings . |