| CTRI Number |
CTRI/2024/08/071868 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Bedside Lung Ultrasound and HRCT Thorax in Diagnosing Acute Chest trauma |
|
Scientific Title of Study
|
To Compare Diagnostic Accuracy Of Bedside Lung Ultrasound With HRCT Thorax in Acute Chest Trauma 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 |
Krishna Chaitanya Gongati |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Emergency Medicine
Ground Floor, SMSC building
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
8374964907 |
| Fax |
|
| Email |
gongatikrishnachaithanya98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Aditya pundkar |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Emergency Medicine
Ground Floor, SMSC building
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9975170898 |
| Fax |
|
| Email |
draditya.pundkar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Aditya pundkar |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Emergency Medicine
Ground Floor, SMSC building
Sawangi Meghe
Wardha
MAHARASHTRA
442001
India |
| Phone |
9975170898 |
| Fax |
|
| Email |
draditya.pundkar@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research Wardha India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Wardha,India 442001 |
| Type of Sponsor |
Private medical college |
|
|
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 Krishna Chaitanya Gongati |
Acharya Vinobhabave Rural Hospital |
Department of Emergency Medicine
Ground Floor SMSC building
Sawangi Meghe
Wardha
MAHARASHTRA |
8374964907
gongatikrishnachaithanya98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Datta Meghe Institute of Higher Education and Research |
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 |
NA |
| Comparator Agent |
NIL |
NA |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Adult population of any gender who sustained chest trauma in a civilian scenario and transferred to Emergency Medicine Department of AVBRH hospital
patients presenting to hospital within 4hours of chest trauma |
|
| ExclusionCriteria |
| Details |
Patients with Penetrating injuries
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the accuracy of bedside lung ultrasound in comparison with HRCT thorax in acute chest trauma patients |
Data will be accessed at the end of 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To study the efficacy of bedside lung ultrasound as a diagnostic tool in emergency setting |
Data will be accessed at the end of 2 years |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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)
|
30/09/2024 |
| 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 Yet Recruiting |
| 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
|
In this study, we aim to evaluate the diagnostic accuracy of bedside lung ultrasonography in comparison to HRCT thorax in patients with acute chest trauma in an emergency setting. |