| CTRI Number |
CTRI/2026/01/101118 [Registered on: 14/01/2026] Trial Registered Prospectively |
| Last Modified On: |
04/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Ultrasound-Guided Versus Landmark Method for Difficult Intravenous Cannulation in Adult Population |
|
Scientific Title of Study
|
Comparison of Ultrasound guided versus conventional method for difficult peripheral intravenous cannulation in adult population |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| none |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Bhawna bansal |
| Designation |
post graduate junior resident emergency medicine |
| Affiliation |
ABVIMS and Dr Ram Manohar Lohia hospital |
| Address |
old emergency building ,ground floor ,department of emergency medicine ,ABVIMS and Dr Ram Manohar Lohia hospital ,110001
Central DELHI 110001 India |
| Phone |
9310689700 |
| Fax |
|
| Email |
bansalbhawna33@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Seema Balkrishna Wasnik |
| Designation |
senior consultant ,department of emergency medicine |
| Affiliation |
ABVIMS and Dr Ram Manohar Lohia hospital ,110001 |
| Address |
old emergency building ,ground floor ,department of emergency medicine ,ABVIMS and Dr Ram Manohar Lohia hospital ,110001
Central DELHI 110001 India |
| Phone |
8527057166 |
| Fax |
|
| Email |
wasnikseema@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Seema Balkrishna Wasnik |
| Designation |
senior consultant ,department of emergency medicine |
| Affiliation |
ABVIMS and Dr Ram Manohar Lohia hospital ,110001 |
| Address |
old emergency building ,ground floor ,department of emergency medicine ,ABVIMS and Dr Ram Manohar Lohia hospital ,110001
Central DELHI 110001 India |
| Phone |
8527057166 |
| Fax |
|
| Email |
wasnikseema@gmail.com |
|
|
Source of Monetary or Material Support
|
| department of emergency medicine ,ABVIMS and Dr RML HOSPITAL New delhi ,pin code 110001, country - india |
|
|
Primary Sponsor
|
| Name |
Dr Bhawna Bansal |
| Address |
department of emergency medicine ,ABVIMS and Dr RML Hospital,110001, delhi |
| 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 |
| Dr Seema Balkrishna Wasnik |
ABVIMS and Dr RML hospital |
old emergency building ,ground floor ,department of emergency medicine ,ABVIMS and Dr Ram Manohar Lohia hospital ,110001 Central DELHI |
08527057166
wasnikseema@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| institutional ethics comittee , ABVIMS and Dr RML hospital New delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Difficult peripheral intravenous cannulation using landmark method |
After meeting with inclusion criteria peripheral intravenous cannulation will be performed using tourniquet and cannula will be placed in the most prominent vein |
| Comparator Agent |
ultrasound guided difficult peripheral intravenous cannulation |
Peripheral intravenous cannulation will be performed under real-time ultrasound guidance using a high-frequency linear transducer. The operator will identify the peripheral vein visually on the ultrasound screen, assess depth and diameter, and perform cannulation under direct visualization using the out-of-plane or in-plane technique as appropriate
Frequency and Duration:
Single procedure per participant (until successful cannulation or a maximum of 3 attempts).
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
A-DIVA score more than 3 |
|
| ExclusionCriteria |
| Details |
1 .patients not giving consent
2. pregnant and lactating mothers
3. very sick patients during presentation requiring central line access |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| success rate of intravenous cannulation on first attempt at the time of presentation in emergency |
success rate of intravenous cannulation on first attempt at the time of presentation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1 number of attempts required for successful cannulation
2 time taken for successful cannulation
3 patient reported pain assessment on VAS scale
|
immediate post procedure and upto one hour post cannulation |
|
|
Target Sample Size
|
Total Sample Size="128" Sample Size from India="128"
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)
|
15/01/2026 |
| 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
|
Comparison of Ultrasound-Guided versus Landmark Method for Difficult Intravenous Cannulation in Adult Population
Peripheral intravenous cannulation is one of the most commonly performed procedures in emergency departments. However, it can be particularly challenging in patients with difficult venous access, leading to multiple failed attempts, patient discomfort, delayed treatment, and increased complications. Traditionally, landmark-based techniques are used to identify suitable veins, but these can be unreliable in difficult access cases due to factors such as obesity, edema, chronic illness, or previous IV drug use.
This prospective, randomized controlled study aims to compare the efficacy and safety of ultrasound-guided versus conventional landmark-based methods for peripheral IV cannulation in adults with difficult venous access in the emergency department. Eligible participants with predefined criteria for difficult IV access will be randomized into two groups one undergoing ultrasound-guided cannulation and the other using the standard landmark technique.
The primary objective is to compare the success rate of cannulation on the first attempt between the two groups. Secondary objectives include comparison of time taken for successful cannulation, number of attempts required, patient-reported pain score, and incidence of complications such as infiltration or hematoma.
The findings of this study may support broader implementation of ultrasound guidance in routine emergency care to improve success rates and patient outcomes. |