Radiographic External Measurement Technique for TIVAP Placement

NCT07549035 | Recruiting

• 1 other identifier: 6814288
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Access Device; Catherization

Keywords

Totally Implantable Venous Access Port; Port Catheter; Central Venous Catheter Catheter Tip Position

Outcome Measures

Primary Outcomes (1)

• Accuracy of Optimal Catheter Tip Positioning

  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)

Study Arms (1)

Chest X-Ray-Based External Measurement Group

EXPERIMENTAL

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.

Procedure: Chest X-Ray-Based External Measurement Method

Interventions

Chest X-Ray-Based External Measurement Method PROCEDURE

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.

Chest X-Ray-Based External Measurement Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Prof. Dr. Cemil Tascıoglu Education and Research Hospital Organization: lead

Study Sites (1)

SBU Bagcilar Education and Training Hospital

Istanbul, ABD Dışında, 34400, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Rasim Onur Karaoglu, MD

CONTACT

00905056814224; rasimonurkaraoglu@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Department of Anesthesiology and Reanimation

Model Details: This is a prospective, single-center, single-group study in which all enrolled participants undergo totally implantable venous access port placement using a chest X-ray-based external measurement method for catheter length determination. Post-procedure chest X-ray is used to evaluate catheter tip position and procedural outcomes.

Study Record Dates

• First Submitted: April 18, 2026
• First Posted: April 23, 2026
• Study Start: April 22, 2026
• Primary Completion (Estimated): June 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

TU (1)