Placement of Peripherally Inserted Central Venous Catheters (PICC) in Children Guided by Ultrasound

This study has been completed.
Sponsor:
Information provided by:
Federal University of São Paulo
ClinicalTrials.gov Identifier:
NCT01279642
First received: January 18, 2011
Last updated: NA
Last verified: July 2010
History: No changes posted
  Purpose

Aimed to compare the success in the peripheral intravenous puncture (PIP), progression and placement of PICC in children, according to the use of Doppler vascular ultrasound (DVUS) or traditional method; to identify the influence of the DUVS in the time expended to PICC placement. Methods: Clinical, randomized and controlled trial conducted after ethical merits of research endorsement and the obtaining of consent for those responsible for the children. The sample, calculated in 42 PICC to obtain a power of 0,85, was distributed randomly into two groups, experimental group (EG) and controlled group (CG). To the statistical analyzes Pearson Chi-square, Fisher's Exact Tests, Generalization of Fischer's Exact and Mann-Whitney tests was applied (5%). Of the 42 catheters, 21 (50.0%) were implemented in EG and 21 (50.0%) in CG. The PIP was obtained in the first attempt in 90.5% of the punctures of the EG and in 47.6% of the GC, (p=0.003). PICC were implanted successfully in 18 (85.7%) children of GE and 11 (61.1%) of CG (p = 0.019). The median of the time spent to the procedure was significantly higher (p=0.001) in CG (50 minutes) when compared to EG (median 20 minutes).


Condition Intervention
Cardiovascular Infections
Peripheral Vascular Disease
Device: ultrasound
Other: traditional puncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Use of Doppler Vascular Ultrasound by Nurses During the Placement of Peripherally Inserted Central Venous Catheters in Children: Clinical, Randomized and Controlled Trial.

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Success in PICC placement. [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The PICC was placed in the first attempt in 90.5% of the punctures of the ultrasound group and in 47.6% of the control group (p=0.003


Secondary Outcome Measures:
  • Time spent to PICC placement [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
    The median time spent to the procedure was significantly higher (p=0.001) in control group (50 minutes) when compared to ultrasound group (median 20 minutes).


Enrollment: 42
Study Start Date: August 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ultrasound
Use of ultrasound to PICC placement
Device: ultrasound
Doppler vascular ultrasound guidance to PICC insertion in children -
Other Names:
  • vascular doppler ultrasound
  • interventional ultrasound
  • vascualr access
Active Comparator: Control group
PICC placement by inspection and visualization of site
Other: traditional puncture
traditional approach of PICC insertion by visualization and inspection of insertion site
Other Name: vascular access

Detailed Description:

Introduction: Peripherally inserted central venous catheters (PICC) are increasingly being used to intravenous therapy in a wide variety of adults and pediatrics patients. Children may have characteristics that could compromise the assertiveness during the catheter placement, even for the more experienced and qualified professionals. In order to search for methods that could lead to the nursing practice innovation seeking for better results in the placement of PICC, this study was designed to analyze the use of Doppler vascular ultrasound (DVUS) to PICC insertion performed by nurses. Objective: To compare the success in the peripheral intravenous puncture (PIP), progression and placement of PICC in children, according to the use of DVUS or traditional method; to identify the influence of the DUVS in the time expended to the placement of PICC in children. Methods: Clinical, randomized and controlled trial conducted in a pediatric surgery ward of a university hospital, from August 17th, 2007 to August 19th, 2008, after ethical merits of research endorsement and the obtaining of consent for those responsible for the children. The sample, calculated in 42 PICC to obtain a power of 0,85, was distributed randomly into two groups, experimental group (EG) and controlled group (CG). The dependent variables were: the success in the PIP, catheter progression and placement. Variables related to children and IV therapy was investigated. To the statistical analyzes Pearson Chi-square, Fisher's Exact Tests, Generalization of Fischer's Exact and Mann-Whitney tests was applied (significance level of 5%). Results: Of the 42 catheters, 21 (50.0%) were implemented in EG and 21 (50.0%) in CG. The PIP was obtained in the first attempt in 90.5% of the punctures of the EG and in 47.6% of the GC, (p=0.003)and the punctures were accomplished to catheter insertion, despite the number of attempts in 76.5% of EG and 41.7% in GC (p = 0.001). The successful to PICC progression was marginally significant result (p=0.069), 69.2% in EG and 44.0% in CG. PICC were implanted successfully in 18 (85.7%) children of GE and 11 (61.1%) of CG (p = 0.019). The median of the time spent to the procedure was significantly higher (p=0.001) in CG (50 minutes) when compared to EG (median 20 minutes). Conclusion: The results obtained lead to the conclusion that the use of USVD to the implementation of the PICC in children promoted greater success in the PIP and in PICC placement, reducing of the time spent to the procedure, but no significant influence was observed regarding the catheter progression.

  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children in IV Therapy for 7 days or more;
  • Peripheral venous vessels indicated to PICC

Exclusion Criteria:

  • Patient or family refuse to consent in PICC insertion.
  • Patient or family refuse to participate in the research.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01279642

Locations
Brazil
Federal University of São Paulo
São Paulo, Brazil, 04024002
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Mavilde LG Pedreira, PhD Federal University of São Paulo
  More Information

No publications provided

Responsible Party: Mavilde LG Pedreira, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT01279642     History of Changes
Other Study ID Numbers: 1967/06, CNPq Grant nº. 476295/2004-1.
Study First Received: January 18, 2011
Last Updated: January 18, 2011
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of São Paulo:
Catheterization, Peripheral
Ultrasonography, Interventional
Nursing
Pediatric

Additional relevant MeSH terms:
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Cardiovascular Infections
Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Infection

ClinicalTrials.gov processed this record on September 30, 2014