Ultrasound-guided Arterial Catheterization in Pediatric Patients

Child Clinical Trial

Official title:

Comparison of Long-axis/In-plane and Short-axis/Out-of-plane Methods During the Ultrasound-guided Arterial Cannulation in Pediatric Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02333786
• Other study ID #: H-1409-095-610
• Status: Completed
• Phase: N/A
• First received: January 5, 2015
• Last updated: October 6, 2015
• Start date: January 2015
• Est. completion date: May 2015

Study information

• Verified date: October 2015
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Investigators designed a prospective randomized controlled study to compare the long-axis/in-plane and short-axis/out-of-plane methods during the ultrasound-guided arterial catheterization in pediatric patients younger than 5 years old.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: May 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

• Surgery under general anesthesia

• Requires invasive arterial blood pressure monitoring

Exclusion Criteria:

• Infection/hematoma/skin disease/arteriovenous fistula/recent catheterization scar in radial artery or posterior tibial artery

• Peripheral vascular disease

• Congenital aortic disease

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Arterial Catheterization
• Child
• Ultrasound

Intervention

Other:
• Long-axis/in-plane US-guided arterial catheterization
Cannulate the radial artery or posterior tibial artery of an infant of a preschool child putting the 24 gauge needle parallel to the ultrasound transducer.
• Short-axis/out-of-plane US-guided arterial catheterization
Cannulate the radial artery or posterior tibial artery of an infant or a preschool child putting the 24 gauge needle perpendicular to the ultrasound transducer.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Arterial catheterization time		Interval between contact of the ultrasound transducer with the skin and confirmation of an arterial waveform on the monitor, an expected average of 200 seconds	No
Secondary	Ultrasound imaging time		Interval between contact of the ultrasound transducer with the skin and penetration of the needle through the skin, an expected average of 30 seconds	No
Secondary	Time to first puncture of the artery		Interval between skin penetration of the needle and flashback of blood, an expected average of 100 seconds	No
Secondary	Number of puncture attempts		Up to 5 times, an expected average observation time of 600 seconds	No