NCT02795468

Brief Summary

The investigators are trying to compare the ultrasound-guided technique vs. palpation method for radial arterial cannulation in infants.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2016

Completed
6 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 10, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
27 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

May 26, 2016

Last Update Submit

April 24, 2018

Conditions

Catheterization, Peripheral

Keywords

PeripheralArterialCatheterization

Outcome Measures

Primary Outcomes (1)

  • First-pass success rate

    Within 10 min from the start time of arterial cannulation using an angiocath

Study Arms (2)

Palpation group

ACTIVE COMPARATOR

The operator will use the pulsation of the radial artery as a guide for the cannulation.

Procedure: Radial arterial cannulation

Ultrasound group

EXPERIMENTAL

The ultrasound guided technique will be used to find a radial artery and insert a radial arterial catheter.

Procedure: Radial arterial cannulation

Interventions

Radial arterial cannulationPROCEDURE

Radial arterial cannulation using usual palpation method or ultrasound guided technique according to the group

Palpation groupUltrasound group

Eligibility Criteria

Age1 Day - 12 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Infants under 12 months age undergoing cardiac surgery with radial arterial cannulation

You may not qualify if:

  • Sign of a skin infection
  • Wound near the puncture site
  • abnormal circulation of the hand
  • any vascular problem at radial or ulnar artery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsung Medical Center

Seoul, 135710, South Korea

Location

Related Publications (2)

  • Huang HP, Zhao WJ, Wen F, Li XY. Application of ultrasound-guided radial artery cannulation in paediatric patients: A systematic review and meta-analysis. Aust Crit Care. 2021 Jul;34(4):388-394. doi: 10.1016/j.aucc.2020.09.001. Epub 2020 Oct 21.

    PMID: 33097369DERIVED

  • Min JJ, Tay CK, Gil NS, Lee JH, Kim S, Kim CS, Yang JH, Jun TG. Ultrasound-guided vs. palpation-guided techniques for radial arterial catheterisation in infants: A randomised controlled trial. Eur J Anaesthesiol. 2019 Mar;36(3):200-205. doi: 10.1097/EJA.0000000000000926.

    PMID: 30431501DERIVED

Study Officials

  • Jong Hwan Lee

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 26, 2016

First Posted

June 10, 2016

Study Start

June 1, 2016

Primary Completion

February 1, 2017

Study Completion

February 28, 2017

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

KR(1)