Peripheral Intravenous Puncture Guided by Vascular Ultrasound

Not Applicable

Completed

• Conditions: Intravenous Therapy Complications; Intravenous Puncture Assertivity; Intravenous Puncture Guided by Vascular Ultrasound
• Interventions: Procedure: IV puncture guided by ultrasound

• Registration Number: NCT00930254
• Lead Sponsor: Federal University of São Paulo

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%).

Study Timeline

• Study Start: 2007-02
• Primary Completion: 2007-11
• Study Completion: 2008-07
• Status Verified: 2009-06
• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-29
• Last Update Submitted: 2009-06-29
• Study First Posted: 2009-06-30
• Last Update Posted: 2009-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 335

Inclusion Criteria

• children submitted to intravenous therapy

Exclusion Criteria

• adults

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound	IV puncture guided by ultrasound	Vascular puncture guided by vascular ultrasound

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

São Paulo Hospital; 🇧🇷 São Paulo, Brazil