NCT02806401

Brief Summary

The purpose of this prospective randomized study was to compare landmark-subclavian venous access to ultrasound-guided axillary venous access when performed by pediatric anesthesiologists.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2016

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

June 1, 2016

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
Last Updated

September 7, 2018

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

June 16, 2016

Last Update Submit

September 5, 2018

Conditions

Ultrasound Guided Central Venous Cannulation

Outcome Measures

Primary Outcomes (1)

  • 2nd access success rate

    interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds

Secondary Outcomes (3)

  • 1st access success rate

    interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds

  • 3rd access success rate

    interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds

  • total time

    interval between skin penetration and removal of the needle or catheter after central line insertion, an expected average of 120 seconds

Study Arms (2)

landmark

EXPERIMENTAL

landmark method\_subclavian venous cannulation

Device: landmark

US_Ax

ACTIVE COMPARATOR

ultrasound guided axillary venous cannulation

Device: US_Ax

Interventions

landmarkDEVICE
landmark
US_AxDEVICE
US_Ax

Eligibility Criteria

Age1 Month - 7 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • surgery under general anesthesia require central venous catheterization

You may not qualify if:

  • hematoma in central vein central vein anomaly catheterization site infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

Location

Study Design

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

Study Record Dates

First Submitted

June 16, 2016

First Posted

June 20, 2016

Study Start

June 1, 2016

Primary Completion

May 1, 2017

Study Completion

August 1, 2017

Last Updated

September 7, 2018

Record last verified: 2018-09

Locations

KR(1)