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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03450785
Other study ID # 1801-152-922
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 7, 2018
Est. completion date April 8, 2020

Study information

Verified date March 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Central venous catheters are frequently used for monitoring haemodynamic status and rapidly delivering fluid therapy during the peri- and postoperative periods. Indwelling central venous catheters are typically used 7-14 days postoperatively for additional monitoring and treatment, but patients may develop asymptomatic catheter-related thrombosis, leading to life-threatening pulmonary embolism and death. Early detection helps to avoid such complications. This prospective observational study investigated the risk factors associated with catheter-related right internal jugular vein thrombosis in pediatric patients. The study enrolled 80 pediatric patients who were scheduled to receive central venous catheter. To detect thrombus formation, Doppler ultrasound examinations from the thyroid cartilage level to the supraclavicular region were used after CVC placement and on each of the following days until the catheter was removed.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date April 8, 2020
Est. primary completion date April 8, 2020
Accepts healthy volunteers No
Gender All
Age group N/A to 6 Years
Eligibility Inclusion Criteria: - pediatric patients who were scheduled to catheterize central venous catheter Exclusion Criteria: - patients who had skin infections on the right side of the neck, making them unsuitable for placement of the catheter via the right side of the neck - patients who had blood coagulation lesions or bleeding tendencies - patients with thrombocytopenia - patients with a history of right internal jugular vein thrombosis - patients who presented right internal jugular vein thrombosis or stenosis on preoperative Doppler ultrasound examination

Study Design


Related Conditions & MeSH terms


Intervention

Other:
ultrasound examination
Doppler ultrasound examinations from the thyroid cartilage level to the supraclavicular region were used after CVC placement and on each of the following days until the catheter was removed.

Locations

Country Name City State
Korea, Republic of Jin-Tae Kim Seoul

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary thrombus formation using doppler ultrasound examination of internal jugular vein after central venous catheter placement and on each of the following days until the catheter was removed (maximum 5 days)
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