Ultrasound IV Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christiana Care Health Services
ClinicalTrials.gov Identifier:
NCT01100593
First received: April 7, 2010
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

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.


Condition Intervention
IV Access
Ultrasound Use
Procedure: length of IV catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Optimal Catheter Length for Ultrasound-Guided Peripheral Vascular Access

Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Extravasation rates [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
    compare catheter length and extravasation rates for US guided peripheral IV insertion in a subset of emergency department patients with difficult IV access


Enrollment: 22
Study Start Date: June 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1.75 inch catheter length
Length of catheter to be used
Procedure: length of IV catheter
Subjects will be randomized to one of two IV catheter lengths
Active Comparator: 2.5 inch catheter length
length of catheter to be used
Procedure: length of IV catheter
Subjects will be randomized to one of two IV catheter lengths

Detailed Description:

The purpose of this study is to compare catheter length and extravasation rates for US guided peripheral IV 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.

The study design is a randomized non-blinded clinical trial of extravasation rates of US guided peripheral vascular access related to intravenous catheter length and venous depth in the ED. Primary endpoint is duration of usable vascular access. Secondary endpoints are catheter length, venous depth, time of procedure, successful cannulation, reasons for failure, number of skin punctures, site of cannulation, sonographic technique, type of provider obtaining access and complications.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • less than age 18
  • subjects needing a central venous catheter
  • patients unable to provide informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01100593

Locations
United States, Delaware
Christiana Care Health Services
Newark, Delaware, United States, 19718
Sponsors and Collaborators
Christiana Care Health Services
Investigators
Study Director: Paul Sierzenski, MD, RDMS Christiana Care Health Services
  More Information

No publications provided

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT01100593     History of Changes
Other Study ID Numbers: 28195
Study First Received: April 7, 2010
Last Updated: November 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Christiana Care Health Services:
Ultrasound
IV catheters
Extravasation

ClinicalTrials.gov processed this record on April 15, 2014