- ICH GCP
- Registre américain des essais cliniques
- Essai clinique 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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
ÇANKAYA
-
Ankara, ÇANKAYA, Turquie (Türkiye), 06800
- Ankara City Hospital Bilkent
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
Accepte les volontaires sains
Méthode d'échantillonnage
Population étudiée
La 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
|
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.
|
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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Agreement between anatomical landmark method and intracavitary electrocardiography for catheter length determination
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Radiographic accuracy of catheter tip position using the anatomical landmark method
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Çağrı Damar, Assoc Prof, Ankara City Hospital Bilkent
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- TABED 1-25-1050
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .