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Completed

NCT Number: NCT07582107

Anatomical Landmark Method for Paediatric Port Catheter Tip Positioning

This study looks at how to place port catheters safely and accurately in children who need long-term intravenous treatment.

For these treatments to work well and to avoid problems such as heart rhythm issues, blood clots, or infections, the tip of the catheter must be in the correct position inside a large vein near the heart.

Doctors commonly use two different methods to estimate the correct catheter length. One method uses body measurements and surface landmarks on the chest. The other method, called intracavitary electrocardiography (IC-ECG), uses changes in the heart's electrical signal during the procedure to guide placement.

In this study, researchers compared these two methods in children. They measured how closely the results of the two techniques matched and how much they differed.

After the catheter was placed, chest X-rays were used to check whether the catheter tip was in the correct position.

The goal of this study is to determine whether the simpler anatomical method can provide accurate and clinically reliable results compared to the IC-ECG method.

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Key information

Age range

1 month–17 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankara City Hospital Bilkent

Ankara, ÇANKAYA, 06800, Turkey (Türkiye)

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Pediatric participants aged between 1 month and 17 years scheduled for elective port catheter placement

Exclusion criteria

  • Participants with central venous anatomical variations or anomalies (such as persistent left superior vena cava or double superior vena cava)
  • Participants with thrombosis in the target veins
  • Participants with skeletal abnormalities, including anterior chest wall deformities or scoliosis
  • Participants for whom parental consent could not be obtained

Treatment and study plan

Anatomical Landmark Method

Procedure

Port catheter placement procedures were performed under ultrasound guidance. To ensure correct positioning of the catheter tip, a length estimation method based on anatomical landmarks was used. This method was developed by reviewing contrast-enhanced chest computed tomography images of pediatric patients without thoracic deformities. In these images, the ideal catheter tip position was identified just above the junction of the superior vena cava and the right atrium. When this point was projected onto the chest wall, it most often corresponded to the upper border of the junction between the right third rib and the sternum. In clinical practice, the distance between the vascular puncture site and this anatomical landmark was measured on the skin using a ruler, and the catheter length was adjusted accordingly before placement.

Intracavitary Electrocardiography (IC-ECG)

Procedure

For each patient, two catheter length measurements were obtained: one using anatomical landmarks and one using intracavitary electrocardiography. Although both measurements were recorded for comparison, the catheter was trimmed and placed according to the anatomical landmark method. Intracavitary electrocardiography is a safe and cost-effective method that allows real-time confirmation of catheter tip position. In this study, a modified approach was created using standard anesthesia monitors. After venous access was established, the proximal end of the sterile guidewire was connected to an electrocardiogram electrode placed on the right shoulder. As the guidewire was advanced, changes in the cardiac P-wave were monitored continuously. The point of maximum P-wave amplitude, corresponding to the junction of the superior vena cava and the right atrium, was identified, and the corresponding intravascular length was recorded.

Primary outcomes

  1. Agreement between anatomical landmark method and intracavitary electrocardiography for catheter length determination

    Time frame: During the procedure

    Assessment of the agreement between catheter length measurements obtained using the anatomical landmark method and intracavitary electrocardiography in pediatric patients undergoing port catheter placement. Measurements obtained by both methods were recorded in the same participants, and the difference between the two techniques was analyzed to evaluate consistency and agreement.

Secondary outcomes

  1. Radiographic accuracy of catheter tip position using the anatomical landmark method

    Time frame: Within 1 day after the procedure

    Evaluation of catheter tip position after placement using the anatomical landmark method based on post-procedural chest X-ray findings. Catheter tip location was classified as appropriate or inappropriate according to predefined radiographic criteria.

Sponsors and collaborators

Lead sponsor

Ankara City Hospital Bilkent

Other

Registry information

Official study title

Validation of a Palpable Anatomical Landmark Method for Tip Positioning of Paediatric Port Catheters Using Modified Intracavitary Electrocardiography: A Prospective Observational Study

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 12, 2026
Registry last updated
May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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