NCT01100593

Brief Summary

The purpose of this study is to compare catheter length and extravasation rates for Ultrasound (US)-guided peripheral intravenous (IV) catheter insertion in a subset of emergency department patients with difficult IV access. Physicians, Emergency RNs, and Emergency Technicians can be taught to use US guidance to start peripheral IV in the ED. The optimal length of catheter to use for this procedure is unknown. This study will provide data on the length of catheter required to minimize extravasation. There is no guideline on catheter length selection for US-guided peripheral vascular access. This study may decrease extravasation rates for US-guided peripheral vascular access by providing guidance on catheter length selection.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 9, 2010

Completed
Last Updated

November 2, 2012

Status Verified

November 1, 2012

Enrollment Period

5 months

First QC Date

April 7, 2010

Last Update Submit

November 1, 2012

Conditions

IV AccessUltrasound Use

Keywords

UltrasoundIV cathetersExtravasation

Outcome Measures

Primary Outcomes (1)

  • Extravasation rates

    compare catheter length and extravasation rates for US guided peripheral IV insertion in a subset of emergency department patients with difficult IV access

    48 hours

Study Arms (2)

1.75 inch catheter length

ACTIVE COMPARATOR

Length of catheter to be used

Procedure: length of IV catheter

2.5 inch catheter length

ACTIVE COMPARATOR

length of catheter to be used

Procedure: length of IV catheter

Interventions

length of IV catheterPROCEDURE

Subjects will be randomized to one of two IV catheter lengths

1.75 inch catheter length2.5 inch catheter length

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • two failed traditional IV attempts by a nurse
  • need for IV access as determined by the treating physician
  • age 18 and greater

You may not qualify if:

  • less than age 18
  • subjects needing a central venous catheter
  • patients unable to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Christiana Care Health Services

Newark, Delaware, 19718, United States

Location

Study Officials

  • Paul Sierzenski, MD, RDMS

    Christiana Care Health Services

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 7, 2010

First Posted

April 9, 2010

Study Start

June 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

November 2, 2012

Record last verified: 2012-11

Locations

US(1)