Peripheral Intravenous Puncture Guided by Vascular Ultrasound

This study has been completed.
Sponsor:
Collaborator:
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT00930254
First received: June 25, 2009
Last updated: June 29, 2009
Last verified: June 2009
  Purpose

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.


Condition Intervention
Intravenous Puncture Assertivity
Intravenous Puncture Guided by Vascular Ultrasound
Intravenous Therapy Complications
Procedure: IV puncture guided by ultrasound

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: Vascular Ultrasound During the Use of Peripheral Intravenous Catheters in Children: A Clinical, Randomized and Controlled Trial.

Further study details as provided by Federal University of São Paulo:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 1 year and 5 months ] [ Designated as safety issue: Yes ]

Enrollment: 335
Study Start Date: February 2007
Study Completion Date: July 2008
Primary Completion Date: November 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ultrasound
Vascular puncture guided by vascular ultrasound
Procedure: IV puncture guided by ultrasound
Comparisons between traditional and ultrasound group
Other Name: vascular ultrasound

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

Ages Eligible for Study:   up to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • children submitted to intravenous therapy

Exclusion Criteria:

  • adults
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00930254

Locations
Brazil
São Paulo Hospital
São Paulo, Brazil, 04024-002
Sponsors and Collaborators
Federal University of São Paulo
Conselho Nacional de Desenvolvimento Científico e Tecnológico
Investigators
Principal Investigator: Ariane FM Avelar, Master Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Ariane Ferreira Machado Avelar, UNIFESP
ClinicalTrials.gov Identifier: NCT00930254     History of Changes
Other Study ID Numbers: USV01, 0402/06
Study First Received: June 25, 2009
Last Updated: June 29, 2009
Health Authority: Brazil: Ethics Committee

Keywords provided by Federal University of São Paulo:
pediatric nursing
peripheral catheterization
ultrasonics
intravenous infusions

ClinicalTrials.gov processed this record on August 28, 2014