NCT02668471

Brief Summary

The purpose of this study is to compare the efficacy of ultrasound- guided with the traditional palpation radial artery cannulation in critically ill children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
84

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2015

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

Study Start

First participant enrolled

August 1, 2015

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2016

Completed
7 days until next milestone

First Posted

Study publicly available on registry

January 29, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2016

Completed
Last Updated

April 27, 2017

Status Verified

April 1, 2017

Enrollment Period

1.1 years

First QC Date

January 22, 2016

Last Update Submit

April 25, 2017

Conditions

Critical Illness

Outcome Measures

Primary Outcomes (1)

  • first attempt success rate of radial artery catheter insertion

    5 minute

Secondary Outcomes (1)

  • time to success of radial artery catheter insertion

    15 minute

Study Arms (2)

Ultrasound guided

EXPERIMENTAL

Radial artery catheters will be placed with the assistance of bedside ultrasound.

Procedure: Ultrasound

traditional method

ACTIVE COMPARATOR

Radial artery catheters will be placed by the palpation technique only.

Procedure: traditional method

Interventions

UltrasoundPROCEDURE

ultrasound at radial site and measure the size and depth of radial artery and perform radial artery cannulation

Ultrasound guided
traditional methodPROCEDURE

Radial artery catheters will be placed by the palpation technique only.

traditional method

Eligibility Criteria

Age1 Month - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Pediatric patients who required radial artery cannulation for hemodynamic monitoring or frequent blood samples in intensive care unit

You may not qualify if:

  • Wound at area of cannulation
  • Can not palpate or weak radial artery pulse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatric,Ramathibodi Hospital

Bangkok, 10400, Thailand

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

Critical Illness

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principle investigator, Pediatric Department, Ramathibodi Hospital

Study Record Dates

First Submitted

January 22, 2016

First Posted

January 29, 2016

Study Start

August 1, 2015

Primary Completion

August 30, 2016

Study Completion

August 30, 2016

Last Updated

April 27, 2017

Record last verified: 2017-04

Locations

TH(1)