- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07549035
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
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
ABD Dışında
-
Istanbul, ABD Dışında, Turkey (Türkiye), 34400
- SBU Bagcilar Education and Training Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
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
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 6814288
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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