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临床试验/CTRI/2025/12/098478
CTRI/2025/12/098478尚未招募不适用

Development and validation of a simplified difficult intravenous access screening tool for perioperative patients

Mahatma Gandhi Medical College and Research Institute1 个研究点 分布在 1 个国家目标入组 1,136 人开始时间: 2025年12月24日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
1,136
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • 1.Age 18 years and above 2.ASA 1 – 4 3.Posted for elective or emergency procedures.

排除标准

  • 1.Patients with pre-existing venous access devices 2.Emergency central venous access.

研究者

申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Rohith R

Mahatma Gandhi Medical College and Research institute, Pondicherry

研究点 (1)

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