NCT00930254

Brief Summary

This research, aimed to verify whether the use of vascular ultrasonography (VUS) could lead to better results in the peripheral venous access implementation in children. Objectives: To compare, regardless of the number of venous puncture attempts, peripheral venous access obtained in children, according to VUS use or traditional method for peripheral intravenous catheter (PIC) insertion; assertiveness in the use of PIC in children, defined as success in the first attempt of puncture and PIC withdrawal according to release of treatment, related to VUS or traditional method and to describe the influence of VUS on PIC dwell time and development of local complications related to the use of intravenous therapy in children.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
335

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Feb 2007

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

February 1, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2008

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

June 25, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 30, 2009

Completed
Last Updated

June 30, 2009

Status Verified

June 1, 2009

Enrollment Period

9 months

First QC Date

June 25, 2009

Last Update Submit

June 29, 2009

Conditions

Keywords

pediatric nursingperipheral catheterizationultrasonicsintravenous infusions

Outcome Measures

Primary Outcomes (1)

  • Venous access obtainment occurred in the two studied groups, with marginally significant statistical difference. The success in the first attempt of puncture was statistically similar.

    1 year and 5 months

Secondary Outcomes (1)

  • The median of catheters dwell time was similar in the control group and experimental group. Infiltration had a different distribution between groups, been more frequent in the Experimental group.

    1 year and 5 months

Study Arms (1)

Ultrasound

EXPERIMENTAL

Vascular puncture guided by vascular ultrasound

Procedure: IV puncture guided by ultrasound

Interventions

Comparisons between traditional and ultrasound group

Also known as: vascular ultrasound
Ultrasound

Eligibility Criteria

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

You may qualify if:

  • children submitted to intravenous therapy

You may not qualify if:

  • adults

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

São Paulo Hospital

São Paulo, São Paulo, 04024-002, Brazil

Location

Related Publications (1)

  • Avelar AF, Peterlini MA, da Pedreira ML. [Assertiveness and peripheral intravenous catheters dwell time with ultrasonography-guided insertion in children and adolescents]. Rev Esc Enferm USP. 2013 Jun;47(3):539-46. doi: 10.1590/s0080-623420130000300003. Portuguese.

Study Officials

  • Ariane FM Avelar, Master

    Federal University of São Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 25, 2009

First Posted

June 30, 2009

Study Start

February 1, 2007

Primary Completion

November 1, 2007

Study Completion

July 1, 2008

Last Updated

June 30, 2009

Record last verified: 2009-06

Locations