- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Kontakte und Standorte
Studienorte
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ÇANKAYA
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Ankara, ÇANKAYA, Türkei (türkiye), 06800
- Ankara City Hospital Bilkent
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
Akzeptiert gesunde Freiwillige
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
Intervention / Behandlung |
|---|---|
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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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Agreement between anatomical landmark method and intracavitary electrocardiography for catheter length determination
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Radiographic accuracy of catheter tip position using the anatomical landmark method
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Çağrı Damar, Assoc Prof, Ankara City Hospital Bilkent
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Andere Studien-ID-Nummern
- TABED 1-25-1050
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