Central Venous Catheterization Techniques in Neonates

Catheterization, Central Venous Clinical Trial

Official title:

Randomized Controlled Trial on Central Venous Catheterization Techniques in Neonates: Seldinger Versus Modified Seldinger

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02688595
• Other study ID #: 1601-108-736
• Status: Completed
• Phase: N/A
• First received: February 17, 2016
• Last updated: January 7, 2018
• Start date: March 2016
• Est. completion date: September 2017

Study information

• Verified date: January 2018
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between the Seldinger and modified Seldinger technique for ultrasound-guided central venous catheterization in neonates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 1 Month

Eligibility

Inclusion Criteria:

• surgery under general anesthesia

• require central venous catheterization

Exclusion Criteria:

• central vein anomaly

• hematoma in central vein

• catheterization site infection

Related Conditions & MeSH terms

• Catheterization, Central Venous

Intervention

Device:
• Ultrasound
Ultrasound-guided central venous catheterization in internal jugular vein

Other:
• General anesthesia
Scheduled operation under general anesthesia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (2)

Grebenik CR, Boyce A, Sinclair ME, Evans RD, Mason DG, Martin B. NICE guidelines for central venous catheterization in children. Is the evidence base sufficient? Br J Anaesth. 2004 Jun;92(6):827-30. Epub 2004 Apr 30. Review. — View Citation

Song IK, Lee JH, Kang JE, Oh HW, Kim HS, Park HP, Kim JT. Comparison of central venous catheterization techniques in pediatric patients: needle vs angiocath. Paediatr Anaesth. 2015 Nov;25(11):1120-6. doi: 10.1111/pan.12726. Epub 2015 Aug 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	First successful central venous catheterization rate		Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes
Secondary	Time to first puncture of central vein		Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds
Secondary	Time to guide wire insertion		Interval between skin penetration and removal of the needle or angiocatheter after guide wire insertion, an expected average of 90 seconds
Secondary	Total time to central venous catheterization		Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes
Secondary	Number of central vein puncture trial		up to 5 times, an expected average observation time of 30 seconds
Secondary	Number of guide wire insertion trial		up to 5 times, an expected average observation time of 90 seconds
Secondary	First successful central vein puncture rate		Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds
Secondary	First successful guide wire insertion rate		Interval between skin penetration and removal of the needle or angiocatheter after guide wire insertion, an expected average of 90 seconds