Clinical trial NCT00930254: Peripheral Intravenous Puncture Guided by Vascular Ultrasound
Official title: Vascular Ultrasound During the Use of Peripheral Intravenous Catheters in Children: A Clinical, Randomized and Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intravenous Puncture Assertivity
Intravenous Puncture Guided by Vascular Ultrasound
Intravenous Therapy Complications
Keywords: pediatric nursing
peripheral catheterization
ultrasonics
intravenous infusions
Lead sponsor: Federal University of São Paulo
Sponsor class: OTHER
Collaborators: name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2009-06-30
Enrollment: 335
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL

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%).

Eligibility criteria: Inclusion Criteria:

* children submitted to intravenous therapy

Exclusion Criteria:

* adults

Primary outcomes:
measure: 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.
timeFrame: 1 year and 5 months
Secondary outcomes:
measure: 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.
timeFrame: 1 year and 5 months
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: São Paulo Hospital
Study officials:
affiliation: Federal University of São Paulo
name: Ariane FM Avelar, Master
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.