- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07582107
Anatomical Landmark Method for Paediatric Port Catheter Tip Positioning
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.
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 Overview
Status
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
ÇANKAYA
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Ankara, ÇANKAYA, Turkey (Türkiye), 06800
- Ankara City Hospital Bilkent
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Agreement between anatomical landmark method and intracavitary electrocardiography for catheter length determination
Time Frame: During the procedure
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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.
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During the procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Radiographic accuracy of catheter tip position using the anatomical landmark method
Time Frame: Within 1 day after the procedure
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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.
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Within 1 day after the procedure
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Çağrı Damar, Assoc Prof, Ankara City Hospital Bilkent
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
Other Study ID Numbers
- TABED 1-25-1050
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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