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Clinical Trials/NCT00930254
NCT00930254
Completed
Not Applicable

Vascular Ultrasound During the Use of Peripheral Intravenous Catheters in Children: A Clinical, Randomized and Controlled Trial.

Federal University of São Paulo1 site in 1 country335 target enrollmentFebruary 2007

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intravenous Puncture Assertivity
Sponsor
Federal University of São Paulo
Enrollment
335
Locations
1
Primary Endpoint
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.
Status
Completed
Last Updated
16 years ago

Overview

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.

Detailed Description

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%).

Registry
clinicaltrials.gov
Start Date
February 2007
End Date
July 2008
Last Updated
16 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Federal University of São Paulo

Eligibility Criteria

Inclusion Criteria

  • children submitted to intravenous therapy

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

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.

Time Frame: 1 year and 5 months

Secondary Outcomes

  • 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 Sites (1)

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