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Peripheral Intravenous Puncture Guided by Vascular Ultrasound

NCT ID: NCT00930254

Last Updated: 2009-06-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

335 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2008-07-31

Brief Summary

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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.

Detailed Description

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Clinical, randomized and controlled trial, conducted in a pediatric surgery ward of a university hospital in São Paulo. Data collection occurred from February 26th, 2007 to July 07th, 2008, after ethical merits of research approval. The sample comprised 382 venous puncture randomly allocated in the experimental group (EG), venous puncture guided by VUS, or in the control group (CG), traditional method of venous puncture. Variables related to children, intravenous therapy and professional characterization were collected. The dependent variables included the obtainment of peripheral venous access, the assertiveness, the catheter dwell time and the occurrence of local complications. For the statistical analysis were applied the Pearson Chi-square, Fisher's Exact, Generalization of Fisher's exact, Mann-Whitney, Likelihood Ratio and Prevalence Ratio (significance level of 5%).

Conditions

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Intravenous Puncture Assertivity Intravenous Puncture Guided by Vascular Ultrasound Intravenous Therapy Complications

Keywords

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pediatric nursing peripheral catheterization ultrasonics intravenous infusions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Ultrasound

Vascular puncture guided by vascular ultrasound

Group Type EXPERIMENTAL

IV puncture guided by ultrasound

Intervention Type PROCEDURE

Comparisons between traditional and ultrasound group

Interventions

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IV puncture guided by ultrasound

Comparisons between traditional and ultrasound group

Intervention Type PROCEDURE

Other Intervention Names

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vascular ultrasound

Eligibility Criteria

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Inclusion Criteria

* children submitted to intravenous therapy

Exclusion Criteria

* adults
Minimum Eligible Age

1 Day

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Conselho Nacional de Desenvolvimento Científico e Tecnológico

OTHER_GOV

Sponsor Role collaborator

Federal University of São Paulo

OTHER

Sponsor Role lead

Responsible Party

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UNIFESP

Principal Investigators

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Ariane FM Avelar, Master

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

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São Paulo Hospital

São Paulo, São Paulo, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type DERIVED
PMID: 24601127 (View on PubMed)

Other Identifiers

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0402/06

Identifier Type: -

Identifier Source: secondary_id

USV01

Identifier Type: -

Identifier Source: org_study_id