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

NCT ID: NCT01279642

Last Updated: 2011-01-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-08-31
• Study Completion Date: 2009-08-31

Brief Summary

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).

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.

Conditions

Cardiovascular Infections; Peripheral Vascular Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ultrasound

Use of ultrasound to PICC placement

Group Type: EXPERIMENTAL

ultrasound

Intervention Type: DEVICE

Doppler vascular ultrasound guidance to PICC insertion in children -

Control group

PICC placement by inspection and visualization of site

Group Type: ACTIVE_COMPARATOR

traditional puncture

Intervention Type: OTHER

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

Interventions

ultrasound

Doppler vascular ultrasound guidance to PICC insertion in children -

Intervention Type: DEVICE

traditional puncture

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

Intervention Type: OTHER

Other Intervention Names

vascular doppler ultrasound; interventional ultrasound; vascualr access; vascular access

Eligibility 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.

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Federal University of São Paulo

OTHER

Sponsor Role: lead

Responsible Party

Federal University of São Paulo

Principal Investigators

Mavilde LG Pedreira, PhD

Role: PRINCIPAL_INVESTIGATOR

Federal University of São Paulo

Locations

Federal University of São Paulo

São Paulo, São Paulo, Brazil

Countries

Brazil

Other Identifiers

CNPq Grant nº. 476295/2004-1.

Identifier Type: OTHER

Identifier Source: secondary_id

1967/06

Identifier Type: -

Identifier Source: org_study_id