| CTRI Number |
CTRI/2026/01/102191 [Registered on: 27/01/2026] Trial Registered Prospectively |
| Last Modified On: |
23/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Randomized Factorial Trial |
|
Public Title of Study
|
COMPARING TWO IMAGING TESTS TO DETECT RIB FRACTURES IN PATIENTS WITH CHEST INJURY |
|
Scientific Title of Study
|
EVALUATING AND COMPARING THE DIAGNOSTIC ACCURACY OF ULTRASOUND PLUS CHEST XRAY VERSUS CHEST XRAY ALONE FOR TRAUMATIC RIB FRACTURES IN EMERGENCY DEPARTMENT PATIENTS |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
ALEN HUSSAIN KALAKKAT |
| Designation |
POST GRADUATE |
| Affiliation |
|
| Address |
VINAYAKA MISSION KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS
CHINNASEERAGAPADI SALEM
VINAYAKA MISSION KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS
SALEM
Salem
TAMIL NADU
636308
India |
| Phone |
9605842248 |
| Fax |
|
| Email |
ALENHUSSAIN1655@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr.SENTHIL KUMAR |
| Designation |
HOD DEPARTMENT OF EMERGENCY MEDICINE |
| Affiliation |
VINAYAKA MISSION KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS |
| Address |
VINAYAKA MISSION KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITAL
VINAYAKA MISSION KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS
SALEM
Salem
TAMIL NADU
636308
India |
| Phone |
9605842248 |
| Fax |
|
| Email |
EDVMKV@GMAIL.COM |
|
Details of Contact Person
Public Query
|
| Name |
ALEN HUSSAIN KALAKKAT |
| Designation |
POST GRADUATE |
| Affiliation |
|
| Address |
KALAKKAT HOUSE AZAD ROAD IRINJALAKUDA THRISSUR
Thrissur
KERALA
680125
India |
| Phone |
9605842248 |
| Fax |
|
| Email |
ALENHUSSAIN1655@GMAIL.COM |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Alen Hussain Kalakkat |
| Address |
kalakkat house azad road irinjalakuda thrissur |
| Type of Sponsor |
Other [] |
|
|
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 |
| ALEN HUSSAIN KALAKKAT |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS |
VINAYAKA MISSIONS KIRUPANANDA VARIYAR MEDICAL COLLEGE AND HOSPITALS, CHINNASEERAGAPADI, SALEM
Salem
TAMIL NADU |
9605842248
alenhussain1655@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: S224||Multiple fractures of ribs, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
ACUTE CASES OF BLUNT CHEST TRAUMA WITH SUSPECTED RIB INJURIES AS EVIDENCED BY INCREASED CHEST WALL PAIN ON COUGH INSPIRATIOIN CHANGE IN POSITION BREATHING DIFFICULTY |
|
| ExclusionCriteria |
| Details |
SEVERE OR PENETRATING CHEST TRAUMA ,UNSTABLE HEMODYNAMICS ,LACK OF CONSENT |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| baseline |
baseline |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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)
|
03/02/2026 |
| 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="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
|
Rib fractures are a common injury following blunt chest trauma and are associated with significant morbidity. Chest X-ray (CXR), the initial imaging modality in the emergency department (ED), has limited sensitivity for detecting rib fractures, particularly non-displaced and occult fractures. Bedside ultrasound is a rapid, radiation-free tool that may improve diagnostic accuracy when used as an adjunct to CXR. This study aims to evaluate and compare the diagnostic accuracy of ultrasound combined with chest X-ray versus chest X-ray alone for detecting traumatic rib fractures in ED patients. The findings may help establish ultrasound as a routine adjunct imaging modality in ED trauma evaluation, enabling earlier diagnosis and improved patient management. |