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Completed

NCT Number: NCT01279642

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

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).

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Key information

Age range

1 month–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Federal University of São Paulo

São Paulo, 04024002, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultrasound

Device

Doppler vascular ultrasound guidance to PICC insertion in children -

Other names: vascular doppler ultrasound, interventional ultrasound, vascualr access

traditional puncture

Other

traditional approach of PICC insertion by visualization and inspection of insertion site

Other names: vascular access

Primary outcomes

  1. Success in PICC placement.

    Time frame: 1 year

    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 outcomes

  1. Time spent to PICC placement

    Time frame: 1 year

    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).

Sponsors and collaborators

Lead sponsor

Federal University of São Paulo

Other

Registry information

Official study 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.

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 19, 2011
Registry last updated
Jan 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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