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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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