Radiographic External Measurement Technique for TIVAP Placement

Accuracy and Clinical Applicability of a Chest X-Ray-Based External Measurement Method for Optimal Catheter Tip Positioning in Totally Implantable Venous Access Port Placement

Totally implantable venous access ports (TIVAPs) are commonly used in patients who need long-term intravenous treatment such as chemotherapy, parenteral nutrition, or repeated blood sampling. Correct placement of the catheter tip is important to reduce the risk of complications, including arrhythmia, thrombosis, catheter dysfunction, vessel injury, and infection.

Several methods are used to determine catheter tip position during port placement, including fluoroscopy, echocardiography, and chest X-ray. However, some of these methods may require additional equipment, increase procedure time, or may not be available in all hospitals.

This study aims to evaluate a simple chest X-ray-based external measurement method to estimate the appropriate catheter length before TIVAP placement. In this method, anatomical landmarks identified on a recent chest X-ray are used to calculate the expected catheter length, which is then applied during the procedure.

The main goal of the study is to assess how accurately this method places the catheter tip in the desired anatomical position. Secondary goals include evaluating the rate of optimal tip placement, procedure-related complications, and the relationship between predicted and actual catheter tip positions.

If successful, this method may provide a practical, low-cost, and widely applicable technique to improve TIVAP placement in routine clinical practice.

Study Overview

Study Type

Interventional

Enrollment (Actual)

69

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • ABD Dışında
      • Istanbul, ABD Dışında, Turkey (Türkiye), 34400
        • SBU Bagcilar Education and Training Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 18 years or older
  • Scheduled for elective totally implantable venous access port placement
  • Available posterior-anterior chest X-ray obtained within the previous 3 months
  • Ability to provide written informed consent

Exclusion Criteria:

  • Known central venous stenosis or occlusion due to previous central venous catheter or port history
  • Congenital heart disease
  • Significant mediastinal anatomical abnormality or distortion
  • Chest X-ray in which anatomical landmarks cannot be clearly identified
  • Emergency port implantation
  • Pregnancy (if required by local ethics policy)
  • Refusal or inability to provide written informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Chest X-Ray-Based External Measurement Group
Participants in this arm undergo totally implantable venous access port placement using a chest X-ray-based external measurement method to determine catheter length before implantation. Anatomical landmarks identified on a recent chest X-ray are used to estimate the target catheter length. Post-procedure chest X-ray is performed to assess final catheter tip position and procedural outcomes.
A pre-procedural measurement technique used during totally implantable venous access port placement. Anatomical landmarks identified on a recent posterior-anterior chest X-ray are used to estimate the appropriate catheter length before implantation in order to optimize final catheter tip position.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of Optimal Catheter Tip Positioning
Time Frame: Immediately after port implantation (within 24 hours)
Proportion of participants with the catheter tip located at the cavoatrial junction or within 1-2 cm proximal to this level on post-procedure chest X-ray.
Immediately after port implantation (within 24 hours)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 6, 2026

Primary Completion (Actual)

May 26, 2026

Study Completion (Actual)

May 27, 2026

Study Registration Dates

First Submitted

April 18, 2026

First Submitted That Met QC Criteria

April 18, 2026

First Posted (Actual)

April 23, 2026

Study Record Updates

Last Update Posted (Actual)

May 29, 2026

Last Update Submitted That Met QC Criteria

May 27, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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