| CTRI Number |
CTRI/2024/10/075942 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
22/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing Waterbath Technique (WBT) with X-Ray for detecting distal hand and foot injuries. |
|
Scientific Title of Study
|
Evaluation of the waterbath ultrasound technique (WBT) in the diagnosis of distal hand and foot injuries in the 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 Tej Prakash Sinha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
JPNATC, AIIMS,NEW DELHI
room no 129 trauma centre AIIMS,NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
08518881749 |
| Fax |
|
| Email |
drsinha123@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tej Prakash Sinha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
JPNATC, AIIMS,NEW DELHI
Room no 129, Trauma centre AIIMS,NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
08518881749 |
| Fax |
|
| Email |
drsinha123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tej Prakash Sinha |
| Designation |
Additional Professor |
| Affiliation |
AIIMS, New Delhi |
| Address |
JPNATC, AIIMS,NEW DELHI
Room no 129, Trauma ce AIIMS,NEW DELHI
New Delhi
DELHI
110029
India |
| Phone |
08518881749 |
| Fax |
|
| Email |
drsinha123@gmail.com |
|
|
Source of Monetary or Material Support
|
| ICMR, V. Ramalingaswami Bhawan, Ansari Nagar,Post box no 4911 New Delhi,(India)110029 |
|
|
Primary Sponsor
|
| Name |
ICMR |
| Address |
V.Ramalingaswami Bhawan, Ansari Nagar, Post Box No. 4911, New Delhi,110029 (India). |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr TEJ PRAKASH SINHA |
JPNATC, AIIMS,NEW DELHI |
Room No. 129, Trauma centre, AIIMS,New Delhi.
New Delhi
DELHI |
08518881749
drsinha123@gmail.com |
| Dr TEJ PRAKASH SINHA |
JPNATC, AIIMS,NEW DELHI |
Room No.129, Trauma centre, AIIMS,New Delhi.
New Delhi
DELHI |
08518881749
drsinha123@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| AIIMS, NEW DELHI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M799||Soft tissue disorder, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
patients presenting to ED with suspected hand and foot fractures will be included. |
|
| ExclusionCriteria |
| Details |
patients with obvious deformity |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Waterbath Ultrasound technique will have higher senstivity and specificity for detecting fractures. |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Waterbath Ultrasound technique (WBT) is more accurate than conventional USG (POCUS) & radiography (X-rays) in identifying distal extremity fractures in the adults population. |
1.5 Years |
|
|
Target Sample Size
|
Total Sample Size="250"
Sample Size from India="250"
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)
|
18/11/2024 |
| 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="6"
Days="1" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
This is a Prospective observational study funded by ICMR with duration of 2.5 years. This study is conducted with an aim to identify occult fractures, foreign body and soft tissue injuries through waterbath technique. All patients presenting to ED with > 18 yrs, suspected fractures will be included. All patients with obvious deformity, hemodynamically unstable patients, patients with open injuries will be excluded. The patient will undergo conventional USG first, then same patient will undergo waterbath ultrasound technique and findings will be compared with gold standard X-Ray. The senstivity, specificity, positive& negative predictive value, positive and negative likelihood ratio will be calculated. |