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

NCT01279642 | Completed DMC

• 2 other identifiers: 1967/06CNPq Grant nº. 476295/2004-1.
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

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).

Conditions

Cardiovascular Infections; Peripheral Vascular Disease

Keywords

Catheterization, Peripheral; Ultrasonography, Interventional; Nursing; Pediatric

Outcome Measures

Primary Outcomes (1)

• Success in PICC placement.

  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

  1 year

Secondary Outcomes (1)

• Time spent to PICC placement

  1 year

Study Arms (2)

ultrasound

EXPERIMENTAL

Use of ultrasound to PICC placement

Device: ultrasound

Control group

ACTIVE COMPARATOR

PICC placement by inspection and visualization of site

Other: traditional puncture

Interventions

ultrasound DEVICE

Doppler vascular ultrasound guidance to PICC insertion in children -

Also known as: vascular doppler ultrasound, interventional ultrasound, vascualr access

ultrasound

traditional puncture OTHER

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

Also known as: vascular access

Control group

Eligibility Criteria

• Age: 1 Month - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patient or family refuse to consent in PICC insertion.
• Patient or family refuse to participate in the research.

Sponsors & Collaborators

• Federal University of São Paulo: lead

Study Sites (1)

Federal University of São Paulo

São Paulo, São Paulo, 04024002, Brazil

Location

MeSH Terms

Conditions

Cardiovascular Infections; Peripheral Vascular Diseases

Interventions

Ultrasonography; Ultrasonography, Interventional; Vascular Access Devices

Condition Hierarchy (Ancestors)

Infections; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative; Catheters; Equipment and Supplies

Study Officials

• Mavilde LG Pedreira, PhD

  Federal University of São Paulo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 18, 2011
• First Posted: January 19, 2011
• Study Start: August 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: January 19, 2011

Record last verified: 2010-07

Locations

BR (1)