Ultrasound-guided Arterial Catheterization in Pediatric Patients

NCT02333786 | Completed DMC

• 1 other identifier: H-1409-095-610
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ultrasound; Arterial Catheterization; Child

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• Time to first puncture of the artery

  Interval between skin penetration of the needle and flashback of blood, an expected average of 100 seconds

• Number of puncture attempts

  Up to 5 times, an expected average observation time of 600 seconds

Study Arms (2)

Infant

EXPERIMENTAL

Radial artery or posterior tibial artery of patients younger than 1 year old are either cannulated with short-axis/out-of-plane or long-axis/in-plane US-guided arterial catheterization technique.

Other: Long-axis/in-plane US-guided arterial catheterization; Other: Short-axis/out-of-plane US-guided arterial catheterization

Preschool child

EXPERIMENTAL

Radial artery or posterior tibial artery of patients older than 1 year old and younger than 5 years old are either cannulated with long-axis/in-plane or short-axis/out-of-plane US-guided arterial catheterization technique.

Other: Long-axis/in-plane US-guided arterial catheterization; Other: Short-axis/out-of-plane US-guided arterial catheterization

Interventions

Short-axis/out-of-plane US-guided arterial catheterization OTHER

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.

Infant; Preschool child

Long-axis/in-plane US-guided arterial catheterization OTHER

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.

Infant; Preschool child

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Surgery under general anesthesia
• Requires invasive arterial blood pressure monitoring

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Seoul, 110-744, South Korea

Location

Related Publications (1)

• Song IK, Choi JY, Lee JH, Kim EH, Kim HJ, Kim HS, Kim JT. Short-axis/out-of-plane or long-axis/in-plane ultrasound-guided arterial cannulation in children: A randomised controlled trial. Eur J Anaesthesiol. 2016 Jul;33(7):522-7. doi: 10.1097/EJA.0000000000000453.

  PMID: 26986774 DERIVED

Study Officials

• Jin-Tae Kim, MD. PhD.

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: January 5, 2015
• First Posted: January 7, 2015
• Study Start: January 1, 2015
• Primary Completion: April 1, 2015
• Study Completion: May 1, 2015
• Last Updated: October 7, 2015

Record last verified: 2015-10

Locations

KR (1)