Ultrasound Assisted Peripheral Venous Access in Young Children

NCT ID: NCT00557154

Last Updated: 2017-02-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2004-07-31

Brief Summary

The purpose of this study is to learn how the use of ultrasound helps with the placement of an intravenous (i.v.) catheter in young children.

Detailed Description

In an academic pediatric Emergency Depratment (ED), we performed a randomized clinical trial of children < 7 years of age, who required i.v. access and who had failed the first i.v. attempt. We randomized patients to either continued standard i.v. attempts or ultrasound-assisted attempts. Clinicians involved in the study received one hour of training in ultrasound localization of peripheral veins. In the ultrasound group, vein localization was performed by an ED physician who marked the skin overlying the target vessel. Intravenous cannulation attempts were then immediately performed by a pediatric ED nurse who relied on the skin mark for vessel location. We allowed for technique cross-over after two failed i.v. attempts. We recorded success rate and location of access attempts.

Conditions

Catheterization, Peripheral

Study Design

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

Study Groups

1

Ultrasound used to visualize peripheral venous anatomy. This guides subsequent attempts at venipuncture.

Group Type: EXPERIMENTAL

ultrasound

Intervention Type: DEVICE

ultrasound used to identify target vein

2

Routine venipuncture using standard methods.

Group Type: ACTIVE_COMPARATOR

standard technique for venipuncture

Intervention Type: DEVICE

routine equipment

Interventions

ultrasound

ultrasound used to identify target vein

Intervention Type: DEVICE

standard technique for venipuncture

routine equipment

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Less than 7 years of age
• Emergency Department patients
• Parents available for consent

Exclusion Criteria

• Critical illness

• Maximum Eligible Age: 7 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Miracle Network

OTHER

Sponsor Role: collaborator

University of California, Davis

OTHER

Sponsor Role: lead

Principal Investigators

Aaron E Bair, MD

Role: PRINCIPAL_INVESTIGATOR

University of California, Davis

Locations

University of California, Davis Medical Center

Sacramento, California, United States

Countries

United States

Other Identifiers

S-9400847-018LA

Identifier Type: OTHER

Identifier Source: secondary_id

200210274

Identifier Type: -

Identifier Source: org_study_id