Complete ultrasound-guided insertion of surgically implanted central venous catheters in children and adolescents - a randomized controlled study
Summary description of the study
For the treatment of certain conditions (especially cancers), patients require so-called central venous catheters. This requires a vein in the neck to be punctured either 'blindly' or under ultrasound guidance. The catheter is then placed into the superior vena cava or the right atrium of the heart. The puncturing of a vein is already performed under ultrasound guidance. Typically, the correct position and course of the catheter is verified under radiological fluoroscopy, which involves ionizing radiation. Despite radiological fluoroscopy, misplacements and complications such as pneumothorax and/or hematothorax can occur. In our institution, in the case of a misplacement, the cardiology colleagues are called in postoperatively, who then confirm, determine, or exclude the correct position using echocardiography. Based on experience from the placement of central venous catheters by the anesthesia and cardiology colleagues, we postulate that we can primarily perform the central venous catheter insertion and placement under ultrasound guidance. Therefore, all children requiring such an intervention are included in the study.
(BASEC)
Intervention under investigation
Success rate of correct placement of the port catheter tube using ultrasound
(BASEC)
Disease under investigation
none
(BASEC)
All children (0-17 years) requiring port catheter implantation (BASEC)
Exclusion criteria
- Age greater than or equal to 18 years - Replacement of an already inserted catheter (BASEC)
Trial sites
Bern
(BASEC)
Sponsor
Inselspital Bern, Kinderchirurgie
(BASEC)
Contact
Contact Person Switzerland
Tobias Krause
031 632 21 11
tobiastjalf.krause@clutterinsel.chInselspital Bern, Kinderchirurgie Freiburgstrasse 15 3010 Bern
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Bern
(BASEC)
Date of authorisation
02.05.2025
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Komplett ultraschallgesteuerte Einlage von chirurgisch implantierten zentralvenösen Kathetern im Kindes- und Jugendalter - eine randomisiert kontrollierte Studie (BASEC)
Academic title
not available
Public title
not available
Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
not available
Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available