| CTRI Number |
CTRI/2025/10/095741 [Registered on: 08/10/2025] Trial Registered Prospectively |
| Last Modified On: |
08/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
prospective observational |
| Study Design |
Other |
|
Public Title of Study
|
point of care ultrasound as diagnostic test in abdominal pain. |
|
Scientific Title of Study
|
An observational study to determine diagnostic accuracy of point of care ultrasound in cases of acute abdominal pain presenting in emergency department. |
| 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 Vaseefat ul zehra |
| Designation |
DNB resident emergency medicine |
| Affiliation |
Medanta, the Medicity |
| Address |
Department of emergency medicine Medanta, the medicity, SECTOR 38
GURUGRAM HARYANA
122001
Gurgaon HARYANA 122001 India |
| Phone |
9149998181 |
| Fax |
|
| Email |
zehra.vaseefatul@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shruti Bansal |
| Designation |
Associate consultant |
| Affiliation |
Medanta, the Medicity |
| Address |
Department of emergency medicine Medanta, the medicity, SECTOR 38
GURUGRAM HARYANA
122001
HARYANA 122001 India |
| Phone |
8130893335 |
| Fax |
|
| Email |
shrutibansalin@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Vaseefat ul zehra |
| Designation |
DNB resident emergency medicine |
| Affiliation |
Medanta, the Medicity |
| Address |
Department of emergency medicine Medanta, the medicity, SECTOR 38
GURUGRAM HARYANA
122001
HARYANA 122001 India |
| Phone |
9149998181 |
| Fax |
|
| Email |
zehra.vaseefatul@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medanta the Medicity
sector 38, Gurugram, Haryana, 122001 |
|
|
Primary Sponsor
|
| Name |
Dr Vaseefat ul Zehra |
| Address |
DNB resident emergency medicine
Medanta, the Medicity
sector 38, gurugram
haryana, 122001 |
| Type of Sponsor |
Other [primary investigator] |
|
|
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 Vaseefat ul zehra |
Medanta the Medicity |
department of emergency medicine
sector 38
Gurugram
Haryana
122001
Gurgaon HARYANA |
9149998181
zehra.vaseefatul@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Medanta Institutional Ethics Commiittee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K929||Disease of digestive system, unspecified, |
|
|
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 |
Patients of age more than 18 years.
Patients with acute onset of abdominal pain. |
|
| ExclusionCriteria |
| Details |
Pediatrics population (age less than 18 years).
Referred cases from outside hospitals with known diagnosis.
Pregnant females. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Diagnostic accuracy of point of care ultrasound in prediction of various causes of acute abdominal pain |
1 hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| sensitivity & specificity of point of care ultrasound in diagnosing various causes of acute abdominal pain. |
1 hour |
| comparison of the time taken by point of care ultrasound in diagnosing the patient with the time taken by traditional methods in diagnosing the causes of acute abdominal pain |
1 hour |
|
|
Target Sample Size
|
Total Sample Size="170" Sample Size from India="170"
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)
|
01/12/2025 |
| 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="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
|
Acute abdominal pain is one of the common causes of emergency department visits and there has been increased use of bedside ultrasound imaging for initial assessment and preliminary diagnosis. Point of care Ultrasonography is a low cost, noninvasive, portable and safe means of energy used to create images with significantly low risk to the patients. It is a bedside imaging used by emergency physicians by performing a target ultrasound of various abdominal organs, correlating the signs and symptoms and helps in providing timely comprehensive management. It is used an adjunct to signs, symptoms and physical examination to make a quick diagnosis, prioritise the investigations and to determine the course of patients.
Acute abdominal pain causes can range from gastrointestinal and genitourinary issues to vascular and infectious conditions and acute coronary syndrome can also present with epigastric pain and therefore often causing a diagnostic dilemma. The common gastrointestinal causes being acute appendicitis, peptic ulcer disease, acute pancreatitis, cholecystitis, diverticulitis, bowel obstruction, ischemic bowel, aortic aneurysm, lacerated injuries of solid organs like spleen and liver, peritonitis intra peritoneal free fluid and different primary bowel and secondary bowel malignancies. Obstetric and gynecologic causes include ovarian torsion, ruptured ectopic pregnancy and pelvis inflammatory disease. Urologic conditions presenting as acute abdominal pain are ureteral colic and pyelonephritis.
Acute abdominal pain requires immediate attention as there is a wide range of causes ranging from self-limiting conditions to several life-threatening conditions like ruptured bowel, aortic aneurysm rupture, mesenteric ischemia, therefore, point of care ultrasound can be used as one of the initial diagnostic procedures as it can significantly contribute to faster diagnosis for the patient [11]. Point of care ultrasound is a dynamic examination which can demonstrate bowel motility and blood flow like inability to compress the bowel indicates pathologies including appendicitis, intussusception and malignancy. It can help to identify key findings like signs of inflammation in acute pancreatitis and acute cholecystitis, free air, ruptured bowel and ruptured ectopic pregnancies. It can detect free fluid of even 10 ml which could be due to different causes like ascites, biliary leak or trauma. It can also precisely give a clearer image for presence of free intra-peritoneal fluid.
In this study we will determine the role and diagnostic accuracy of point of care ultrasound in determining various causes of acute onset abdominal pain presenting to emergency department. |