NCT02912481

Brief Summary

Arterial catheterization in small children is challenging, even for experienced anesthesiologists. For successful arterial catheterization, the arterial diameter, cross-sectional area, and depth from the skin surface are important considerations, especially in pediatric patients. THe investigators examined the posterior tibial artery (PTA) and dorsalis pedis artery (DPA) using ultrasound (US) to find a reasonable alternative arterial cannulation site to the radial artery (RA) in pediatric patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
275

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 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

Study Start

First participant enrolled

September 1, 2016

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

September 21, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 23, 2016

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

September 6, 2017

Status Verified

September 1, 2017

Enrollment Period

6 months

First QC Date

September 21, 2016

Last Update Submit

September 4, 2017

Conditions

Arterial Catheterization

Outcome Measures

Primary Outcomes (1)

  • first access success rate

    immediate after anesthetic induction, maximum 10 minutes

Study Arms (3)

Posterior tibial artery

EXPERIMENTAL

real time ultrasound guided arterial catheterization on the posterior tibial artery

Procedure: posterior tibial artery

Radial artery

ACTIVE COMPARATOR

real time ultrasound guided arterial catheterization on the radial artery

Procedure: radial artery

Dorsalis pedis artery

ACTIVE COMPARATOR

real time ultrasound guided arterial catheterization on the dorsalis pedis artery

Procedure: dorsalis pedis artery

Interventions

posterior tibial arteryPROCEDURE
Posterior tibial artery
radial arteryPROCEDURE
Radial artery
dorsalis pedis arteryPROCEDURE
Dorsalis pedis artery

Eligibility Criteria

AgeUp to 2 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • Patients undergoing general anesthesia needing invasive arterial monitoring

You may not qualify if:

  • Surgery involving the both hands or foots

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

SNUH

Seoul, Jongro Gu, 15710, South Korea

Location

Study Design

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

Study Record Dates

First Submitted

September 21, 2016

First Posted

September 23, 2016

Study Start

September 1, 2016

Primary Completion

March 1, 2017

Study Completion

July 1, 2017

Last Updated

September 6, 2017

Record last verified: 2017-09

Locations

KR(1)