| CTRI Number |
CTRI/2017/08/009289 [Registered on: 08/08/2017] Trial Registered Prospectively |
| Last Modified On: |
08/08/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To see for DVT using compression ultrasound in patients posted for orthopaedic lower limb surgeries. |
|
Scientific Title of Study
|
Observational study to detect the rate of DVT in the patient undergoing orthopaedic lower limb surgeries using compression ultrasound
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shalini Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr Rajendra Prasad Govt. Medical College Tanda |
| Address |
Deptt. of Anaesthesia;
Dr Rajendra Prasad Govt. Medical College Tanda.
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418011121 |
| Fax |
|
| Email |
shalini.medico@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shalini Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr Rajendra Prasad Govt. Medical College Tanda at Kangra |
| Address |
Deptt. of Anaesthesia;
Dr Rajendra Prasad Govt. Medical College Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418011121 |
| Fax |
|
| Email |
shalini.medico@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Shalini Sharma |
| Designation |
Assistant Professor |
| Affiliation |
Dr Rajendra Prasad Govt. Medical College Tanda at Kangra |
| Address |
Deptt. of Anaesthesia;
Dr Rajendra Prasad Govt. Medical College Tanda
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9418011121 |
| Fax |
|
| Email |
shalini.medico@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad Govt. Medical College Tanda at Kangra. |
|
|
Primary Sponsor
|
| Name |
Shalini Sharma |
| Address |
Department of Anaesthesia;
DRPGMC Tanda |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Shalini Sharma |
Dr Rajendra Prasad Govt. Medical College Tanda. |
Deptt. of Anaesthesia;
Dr Rajendra Prasad Govt. Medical College Tanda
Kangra
HIMACHAL PRADESH |
9418011121
shalini.medico@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 |
Patients posted for orthopaedic lower limb surgeries., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
A SonoSite® MicroMaxx® ultrasound system (SonoSite INC, Bothell, WA |
Linear transducer will be used to detect any evidence of deep vein thrombosis in common femoral vein, superficial femoral vein and popliteal vein. |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
1. Age >12years.
2. Lower limb long bone fractures.
|
|
| ExclusionCriteria |
| Details |
1. Refusal to give consent.
2. Haemodynamically unstable patient requiring emergency surgery.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| All the patients will be assessed for evidence of DVT on compression ultrasound. |
The patients will be assessed for evidence of DVT after the desired level of sensory and motor blockade is achieved on giving regional anaesthesia before the start of surgery. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
14/08/2017 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The present observational study will be conducted in the department of anaesthesia at DRPGMC tanda. All the patients of lower
limb trauma posted for surgery will be included in this prospective study. After attaching standard monitors, regional anaesthesia will be given to the patient. After the adequate level of sensory and motor blockade is achieved, compression ultrasound (CUS) will be
done by the investigator. Bilateral sequential compressions
along the common femoral vein, the superficial femoral vein and the popliteal vein will be done. Any evidence of deep vein thrombosis will be noted.
|