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CTRI Number  CTRI/2025/12/098478 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 02/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Single Arm Study 
Public Title of Study   Testing a simple tool to identify surgery patients who may have difficulty getting an intravenous access 
Scientific Title of Study   Development and validation of a simplified difficult intravenous access screening tool for perioperative patients 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohith R 
Designation  Post graduate 
Affiliation  Mahatma Gandhi Medical College and Research institute, Pondicherry  
Address  Room no 211, Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute, Pondicherry.

Pondicherry
PONDICHERRY
607403
India 
Phone  8838291571  
Fax    
Email  rrohiii1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Charulatha R 
Designation  Professor  
Affiliation  Mahatma Gandhi Medical College and Research Institute Pondicherry.  
Address  Room no 211, Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute, Pondicherry.

Pondicherry
PONDICHERRY
607403
India 
Phone  9894909652  
Fax    
Email  ravindrancharulatha@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Charulatha R 
Designation  Professor  
Affiliation  Mahatma Gandhi Medical College and Research Institute Pondicherry.  
Address  Room no 211, Department of Anaesthesiology, Mahatma Gandhi Medical College and Research Institute, Pondicherry.

Pondicherry
PONDICHERRY
607403
India 
Phone  9894909652  
Fax    
Email  ravindrancharulatha@gmail.com  
 
Source of Monetary or Material Support  
Mahatma gandhi medical college and research institute, Pondicherry-cuddalore road, ECR, Pillayarkuppam, Puducherry, India,607403.  
 
Primary Sponsor  
Name  Mahatma Gandhi Medical College and Research Institute  
Address  Pondicherry-Cuddalore road, ECR, Pillayarkuppam, Puducherry 607403 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
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 Charulatha R  Mahatma Gandhi Medical College Hospital   Mahatma Gandhi Medical College Hospital, Second floor, Department of Anaesthesiology, Pillayarkuppam, Pondicherry 607402.
Pondicherry
PONDICHERRY 		 9894909652

ravindrancharulatha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Human Ethics Committee (IHEC)   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 
Comparator Agent  NIL  NIL 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1.Age 18 years and above
2.ASA 1 – 4
3.Posted for elective or emergency procedures
 
 
ExclusionCriteria 
Details  1.Patients with pre-existing venous access devices
2.Emergency central venous access
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
First-attempt success of peripheral intravenous cannulation (PIVC) using an 18G cannula in peri-operative patients by an experienced provider in a recruited vein more than 3 mm in diameter
 		 10 minutes
 
 
Secondary Outcome  
Outcome  TimePoints 
Number of attempts  20 minutes 
Size of vascular access device  20 minutes 
Vein visibility  20 minutes 
Vein diameter  20 minutes 
Cannulation site  20 minutes 
Use of ultrasound  20 minutes 
Vein palpability  20 minutes 
 
Target Sample Size   Total Sample Size="1136"
Sample Size from India="1136" 
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)   24/12/2025 
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 Yet Recruiting 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rrohiii1999@gmail.com].

  6. For how long will this data be available start date provided 01-09-2027 and end date provided 01-09-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This prospective observational diagnostic validation study aims to develop and validate a simplified two item screening tool to identify perioperative patients at risk of Difficult Intravenous Access (DIVA), a significant challenge associated with multiple cannulation attempts, patient discomfort, procedural delays, and increased complications. Existing DIVA prediction tools though effective, often involve multiple variables and are not optimized for rapid perioperative screening. The proposed tool evaluates two clinically relevant predictors such as poor vein visibility or palpability despite tourniquet application and the presence of fragile, slippery veins, to provide a rapid, practical assessment tailored to anesthetic workflows. Adult patients undergoing surgery at Mahatma gandhi medical college and research institute(MGMCRI)will be screened preoperatively, followed by standardized peripheral IV cannulation performed by senior residents or consultants, with outcomes including number of attempts, ultrasound use, and complications being recorded. The study will evaluate the new tool’s diagnostic accuracy using sensitivity, specificity, predictive values, and ROC curve analysis, and will compare its performance with existing tools. Inter rater reliability will be assessed using Cohen’s kappa, and logistic regression will identify independent predictors of cannulation success after adjusting for confounders including age, Body Mass Index(BMI), and comorbidities. By addressing the need for a quick, objective, and user friendly Difficult Intravenous Access ( DIVA)  assessment method, this research seeks to enhance early identification of high risk patients, optimize vascular access strategies, reduce failed attempts, and improve perioperative efficiency and patient safety. Ethical approval will be obtained, informed consent will be secured from all participants, and confidentiality will be strictly maintained. The findings are expected to support the implementation of the two item Difficult Intravenous Access (DIVA) tool as a valuable addition to routine perioperative assessment and anesthetic practice. 
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