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Ultrasound IV Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01100593
First Posted: April 9, 2010
Last Update Posted: November 2, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Christiana Care Health Services
  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
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Optimal Catheter Length for Ultrasound-Guided Peripheral Vascular Access

Resource links provided by NLM:


Further study details as provided by Christiana Care Health Services:

Primary Outcome Measures:
  • Extravasation rates [ Time Frame: 48 hours ]
    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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Christiana Care Health Services
ClinicalTrials.gov Identifier: NCT01100593     History of Changes
Other Study ID Numbers: 28195
First Submitted: April 7, 2010
First Posted: April 9, 2010
Last Update Posted: November 2, 2012
Last Verified: November 2012

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