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Determination of Central Venous Catheter (CVC) Location and Exclusion of Pneumothorax by Sonography in Children Treated by Cardiac Surgery-BLAZE Trial.

Determination of Central Venous Catheter (CVC) Location and Exclusion of Pneumothorax by Sonography in Children Treated by Cardiac Surgery-BLAZE Trial. - BLAZE

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00025327
Enrollment
100
Registered
2021-05-26
Start date
2021-06-01
Completion date
Unknown
Last updated
2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

OPS-5399.5

Interventions

Group 1: Monocentric, prospective observational study. Patients in the pediatric cardiology/cardiac surgery department who are undergoing a procedure under general anesthesia and for whom a CVC is ind

Sponsors

Universitätsklinikum Bonn
Lead Sponsor

Eligibility

Sex/Gender
All
Age
No minimum to 14 Years

Inclusion criteria

Inclusion criteria: Patients in the pediatric cardiology/cardiac surgery department who are undergoing a procedure under general anesthesia and for whom a CVC is indicated due to the procedure or their preexisting conditions. Age Up to 14 years Prior informed consent and informed, written consent of the parent/legal guardian

Exclusion criteria

Exclusion criteria: Children with an existing CVC or children for whom a CVC is not necessary for the operation. Lack of informed consent from the parent/guardian. >ASA 4 Emergency

Design outcomes

Primary

MeasureTime frame
What is the percentage of sonographically guided catheter installations that had to be corrected after radiological control with regard to the definitive position? If the legal guardians agree to participate in the study, on the day of the operation the neck vessels and the course of the child are first examined sonographically under sedation or general anesthesia in preparation. This procedure is already standard practice at our hospital. The examination is advanced without interruption by moving the ultrasound probe distally to the right supraclavicular anlage point. After appropriate image optimization and manipulation of the ultrasound probe, the superior vena cava is visualized in its entire course. This is followed by right parasternal plumbing to visualize the superior vena cava. Subsequently, the confluence of the superior vena cava with the right atrium is visualized from the subcostal side. Finally, a bicaval plumbing is visualized from the right parasternal side in the right lateral position. This preliminary examination serves to identify the optimal sonographic window for visualization of the superior vena cava as the target localization for the CVC tip. Further preparation for sonographically guided CVC insertion is performed under sterile conditions after disinfection of the puncture site. The ultrasound probe is covered with a commercially available sterile sheath. Puncture of the vein (internal jugular vein dextra) is performed under direct ultrasound vision with a puncture needle in standard practice of our clinic. After successful puncture, the catheter is placed in usual technique, but 10% deeper than calculated by standard formula. The ultrasound probe is now placed on the previously determined "best sonic window". The catheter tip is identified and the distance to the junction of the vena cava sup. and right atrium is measured by sonography. The CVC is then retracted by this exact distance and fixed in place. A systematic transthoracic ultraso

Secondary

MeasureTime frame
Which factors on the patient side lead to the fact that the CVC tip cannot be visualized sonographically? What is the discrepancy in the examination result between the transthoracic ultrasound of the pleura and the chest X-ray? What is the best sonographic window? In what percentage of cases is there radiographic evidence of pneumothorax?

Countries

Germany

Contacts

Public ContactClaudia Neumann

Universitätsklinikum Bonn

claudia.neumann@ukbonn.de0228 287 14114

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026