| CTRI Number |
CTRI/2022/06/043457 [Registered on: 23/06/2022] Trial Registered Prospectively |
| Last Modified On: |
05/06/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To study the success rate of first time success in securing iv cannula with the help of ultrasound when compared with usual method by emergency physicians |
|
Scientific Title of Study
|
To study the first pass success rate of ultrasound guided peripheral intravenous access in difficult intravenous access patients(DIVA) when compared to traditional methods with training in emergency care providers |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sreedevi Aravindan |
| Designation |
Junior Resident |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
New Emergency
Department of emergency medicine
New Delhi
South
DELHI
110049
India |
| Phone |
8375901844 |
| Fax |
|
| Email |
sreedeviaravindan570@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
L R Murmu |
| Designation |
Professor |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
New emergency
Department of emergency medicine
AIIMS
New delhi
South
DELHI
110049
India |
| Phone |
9968261616 |
| Fax |
|
| Email |
lrmurmu@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SREEDEVI ARAVINDAN |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
All India Institute Of Medical Sciences |
| Address |
New emergency
Department of emergency medicine
AIIMS
New delhi
South
DELHI
110029
India |
| Phone |
8375901844 |
| Fax |
|
| Email |
sreedeviaravindan570@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute Of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
All India Institute Of Medical Sciences |
| Address |
Department Of Emergency Medicine
All India Institute Of Medical Sciences |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sreedevi Aravindan |
All India Institute Of Medical Sciences, New Delhi |
Department Of Emergency Medicine ,
All India Institute Of Medical Sciences
New Delhi
South
DELHI |
8375901844
sreedeviaravindan570@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, ALL INDIA INSTITUTE OF MEDICAL SCIENCES |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Placement of intravenous access by traditional palpatory method |
Placement of intravenous access by traditional palpatory method
Duration 2 years |
| Intervention |
Ultrasound guided Intravenous Access |
Ultrasound guided Intravenous Access in patients with Difficult Intravenous Access
Duration of 2 years |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Patients with difficult intravenous access coming to Emergency
|
|
| ExclusionCriteria |
| Details |
Patients with unstable vitals requiring immediate resuscitation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study the first pass success rate of ultrasound guided peripheral intravenous access in difficult intravenous access patients(DIVA) when compared to traditional methods with training in emergency care providers |
For a period of 18 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare the rate of performing ultrasound guided peripheral intravenous cannulation among first , second and third year academic junior residents in emergency medicine |
Assessment at the end of 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="160"
Sample Size from India="160"
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)
|
30/06/2022 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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)?
Response - NO
|
|
Brief Summary
|
I will be trained by the faculty in performing ultrasound guided peripheral iv cannulation and i will be evaluated regarding my skills. once the training is completed i will study the first pass success rate in ultrasound guided peripheral access in difficult intravenous access patients when compared to traditional palpatory method . Randomization will be performed using alternative nquery advisor |