Intravenous Puncture Assertivity Clinical Trial
Official title:
Vascular Ultrasound During the Use of Peripheral Intravenous Catheters in Children: A Clinical, Randomized and Controlled Trial.
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.
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%). ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label