Risk Prediction Model for Iodinated Contrast Medium Extravasation (RPMICME)

Development and Validation of a Risk Prediction Model for Iodinated Contrast Medium Extravasation in Patients Undergoing Contrast-enhanced Computed Tomography

This study aims to develop a risk prediction model for iodine contrast agent extravasation from peripheral veins and to implement this model clinically to establish a risk control management system for iodine contrast agent extravasation.A case-control study design was employed to collect data for model development. The case group comprised patients who experienced iodine contrast agent extravasation during enhanced CT examinations, while the control group included patients who underwent similar examinations without extravasation.

Study Overview

• Status: Recruiting
• Conditions: Extravasation of Contrast Media

Detailed Description

In this study, a retrospective case-control design was utilized to collect data from patients who underwent enhanced CT examinations at our medical center. In line with the nursing management protocols of our center, all cases of iodine contrast extravasation require treatment and follow-up, necessitating the creation of an electronic record for each affected patient. During the establishment of these records, researchers obtained consent from the affected patients to include them in the study. Upon receiving approval, relevant data from the records were extracted for research purposes. For the non-extravasation group, researchers approached eligible patients or their guardians after the examination, explained the study's objectives, and collected pertinent data through Electronic Medical Record System after obtaining informed consent.

The collected data encompass general demographic information (including age, gender, height, and weight), medical history (including conditions such as malignant tumors, chemotherapy treatments, hypertension, and diabetes), and examination parameters (including specific examination items, types of contrast agents, injection dosages, and flow rates). Additionally, the dataset includes venous access details (such as vascular conditions, peripheral venous catheter insertion sites, and catheter models) and environmental factors (such as maximum and minimum temperatures and temperature variations).

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Qin Li
• Study Contact Backup: Name: Wenyan Zhang, Master; Phone Number: 0086-027-83663493; Email: callmeanna1986@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • TongjiHospital
      • Contact: Wenyan Zhang, Master; Phone Number: 0086-027-83663493; Email: callmeanna1986@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients who received enhanced CT scans via peripheral venous indwelling needle.

Description

Inclusion Criteria:

1. Volunteer to participate in this study.
2. Without contraindications such as iodine contrast allergy or hyperthyroidism. -

Exclusion Criteria:

1. There are communication barriers between researchers and patients.
2. Due to critical condition or unstable vital signs, patients should be transferred to relevant clinical departments for treatment or observation immediately after examination.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
accuracy of prediction model	the ratio of correct predictions to the total number of model predictions(%)	through study completion, an average of 1 year
the incidence of peripheral venous iodine contrast agent extravasation	the number of iodine contrast agent extravasation times divided by the total number of enhanced CT examinations during the same period(%)	One year before and after the prediction model is put into use.

Collaborators and Investigators

• Sponsor: Zhang Wenyan
• Investigators: Principal Investigator: Wenyan Zhang, Master, Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): November 30, 2026

Study Registration Dates

• First Submitted: February 24, 2025
• First Submitted That Met QC Criteria: February 27, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 27, 2025
• Last Verified: February 1, 2025

More Information

Terms related to this study

• Keywords: Risk Management; Extravasation of Contrast Media; Predictive Models; Machine
• Additional Relevant MeSH Terms: Wounds and Injuries; Pathologic Processes; Extravasation of Diagnostic and Therapeutic Materials
• Other Study ID Numbers: myanna2010; 2024D24 (Other Grant/Funding Number: TongjiHospital)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No