Central Venous CatheterizationNCT07582107
Anatomical Landmark Method for Paediatric Port Catheter Tip Positioning
An observational study of Central Venous Catheterization and Vascular Access Devices, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 1 month to 17 years
- Conditions the study is for
- Central Venous Catheterization, Vascular Access Devices, Pediatric Patients
- What is being tested?
- Anatomical Landmark Method and Intracavitary Electrocardiography (IC-ECG)
- Type of treatment
- Surgery or procedure
- How many people
- 53 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Nov 2024to 30 Apr 2025
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 month to 17 years
- All sexes
- Child
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.
Who may be able to join
- Pediatric participants aged between 1 month and 17 years scheduled for elective port catheter placement
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara City Hospital Bilkent
Ankara, ÇANKAYA, 06800
About this study
Official title: Validation of a Palpable Anatomical Landmark Method for Tip Positioning of Paediatric Port Catheters Using Modified Intracavitary Electrocardiography: A Prospective Observational Study
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.
Read more
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.
- Being tested
- Anatomical Landmark Method, Intracavitary Electrocardiography (IC-ECG)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical Landmark MethodProcedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Anatomical Landmark Method; Procedure: Intracavitary Electrocardiography (IC-ECG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: During the procedure
Secondary outcomes (1)
Radiographic accuracy of catheter tip position using the anatomical landmark method
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.
Measured: Within 1 day after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Nov 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 53 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Ankara City Hospital Bilkent
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Çağrı Damar, Assoc Prof, Principal investigator, Ankara City Hospital Bilkent
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07582107
- Sponsor's protocol ID
- TABED 1-25-1050
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Palpable Anatomical Landmark Method for Tip Positioning of Paediatric Port Catheters Using Modified Intracavitary Electrocardiography: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07582107
- Acronym / sponsor ID
- TABED 1-25-1050
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Ankara City Hospital BilkentUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pediatric patients undergoing port catheter placement | – | Procedure: Anatomical Landmark Method, Procedure: Intracavitary Electrocardiography (IC-ECG)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. |
Who may qualify
- Ages
- 1 month to 17 years
- Sex
- All
- Age groups
- Child
- 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.
Key inclusion criteria (1 listed)
- Pediatric participants aged between 1 month and 17 years scheduled for elective port catheter placement
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anatomical Landmark MethodPort 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. | Procedure or surgery | Pediatric patients undergoing port catheter placement |
| Intracavitary Electrocardiography (IC-ECG)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. | Procedure or surgery | Pediatric patients undergoing port catheter placement |
Primary outcome
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.
1 secondary outcome
Radiographic accuracy of catheter tip position using the anatomical landmark method
Time frame: Within 1 day after the procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Çağrı Damar, Assoc Prof principal investigator
Ankara City Hospital Bilkent
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Venous Catheterization and Vascular Access Devices, run by Ankara City Hospital Bilkent at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between anatomical landmark method and intracavitary electrocardiography for catheter length determination (time frame: During the procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.