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Anatomical Landmark Method for Paediatric Port Catheter Tip Positioning

6. maj 2026 opdateret af: Ankara City Hospital Bilkent

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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

53

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Tyrkiet (Türkiye)
    • ÇANKAYA
      • Ankara, ÇANKAYA, Tyrkiet (Türkiye), 06800
        • Ankara City Hospital Bilkent

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn

Tager imod sunde frivillige

N/A

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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
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.
Procedure: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Agreement between anatomical landmark method and intracavitary electrocardiography for catheter length determination
Tidsramme: 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.
During the procedure

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Radiographic accuracy of catheter tip position using the anatomical landmark method
Tidsramme: 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.
Within 1 day after the procedure

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ankara City Hospital Bilkent

Efterforskere

  • Ledende efterforsker: Çağrı Damar, Assoc Prof, Ankara City Hospital Bilkent

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. november 2024

Primær færdiggørelse (Faktiske)

30. april 2025

Studieafslutning (Faktiske)

30. april 2025

Datoer for studieregistrering

Først indsendt

6. maj 2026

Først indsendt, der opfyldte QC-kriterier

6. maj 2026

Først opslået (Faktiske)

12. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

12. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • TABED 1-25-1050

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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Placeringer

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