Anatomical Landmark Method for Paediatric Port Catheter Tip Positioning

NCT07582107 | Completed

• 1 other identifier: TABED 1-25-1050
• Study Type: observational
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Vascular Access Devices; Pediatric Patients; Central Venous Catheterization; Monitoring

Outcome Measures

Primary Outcomes (1)

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

  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.

  During the procedure

Secondary Outcomes (1)

• Radiographic accuracy of catheter tip position using the anatomical landmark method

  Within 1 day after the procedure

Study Arms (1)

Pediatric patients undergoing port catheter placement

Children undergoing port catheter placement in whom catheter length was assessed using both the anatomical landmark method and intracavitary electrocardiography (IC-ECG) within the same procedure.

Procedure: Anatomical Landmark Method; Procedure: Intracavitary Electrocardiography (IC-ECG)

Interventions

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.

Pediatric patients undergoing port catheter placement

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.

Pediatric patients undergoing port catheter placement

Eligibility Criteria

• Age: 1 Month - 17 Years
• Sex: all
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric participants aged between 1 month and 17 years who underwent elective port catheter placement at a tertiary care center. All procedures were performed under standardized conditions, and participants were evaluated using both anatomical landmark-based measurements and intracavitary electrocardiography during the same procedure.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ankara City Hospital Bilkent: lead

Study Sites (1)

Ankara City Hospital Bilkent

Ankara, ÇANKAYA, 06800, Turkey (Türkiye)

Location

Study Officials

• Çağrı Damar, Assoc Prof

  Ankara City Hospital Bilkent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: November 1, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: May 12, 2026

Record last verified: 2026-05

Locations

TU (1)