Peripheral Intravenous Puncture Guided by Vascular Ultrasound

Intravenous Puncture Assertivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00930254
• Other study ID #: USV01
• Secondary ID: 0402/06
• Status: Completed
• Phase: N/A
• First received: June 25, 2009
• Last updated: June 29, 2009
• Start date: February 2007
• Est. completion date: July 2008

Study information

• Verified date: June 2009
• Source: Federal University of São Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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%).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 335
• Est. completion date: July 2008
• Est. primary completion date: November 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 18 Years

Eligibility

Inclusion Criteria:

• children submitted to intravenous therapy

Exclusion Criteria:

• adults

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

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

Intervention

Procedure:
• IV puncture guided by ultrasound
Comparisons between traditional and ultrasound group

Locations

Country	Name	City	State
Brazil	São Paulo Hospital	São Paulo

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of São Paulo	Conselho Nacional de Desenvolvimento Científico e Tecnológico

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes