General information
  • Disease category Surgery (BASEC)
  • Recruitment status recruitment not started yet (BASEC/ICTRP)
  • Trial sites
    Bern
    (BASEC)
  • Contact Tobias Krause tobiastjalf.krause@insel.ch (BASEC)
  • Data Source(s) BASEC: Import from 02.05.2025 ICTRP: N/A
  • Last update 02.05.2025 12:05
HumRes66826 | SNCTP000006388 | BASEC2024-01814

Complete ultrasound-guided insertion of surgically implanted central venous catheters in children and adolescents - a randomized controlled study

  • Disease category Surgery (BASEC)
  • Recruitment status recruitment not started yet (BASEC/ICTRP)
  • Trial sites
    Bern
    (BASEC)
  • Contact Tobias Krause tobiastjalf.krause@insel.ch (BASEC)
  • Data Source(s) BASEC: Import from 02.05.2025 ICTRP: N/A
  • Last update 02.05.2025 12:05

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)

Criteria for participation in trial
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)

not available

Sponsor

Inselspital Bern, Kinderchirurgie

(BASEC)

Contact

Contact Person Switzerland

Tobias Krause

031 632 21 11

tobiastjalf.krause@insel.ch

Inselspital 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

not available

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