Ultrasound IV Study | NCT01100593

Studies
Ultrasound IV Study

NCT01100593

Sponsor

Christiana Care Health Services

Status

Completed

Last Update Posted

Nov 2, 2012Estimated

Enrollment

22Actual

Phase

Not Applicable

Conditions

IV Access
Ultrasound Use

Interventions

length of IV catheter

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Apr 7, 2010

First Submission Date that Met QC Criteria

Apr 7, 2010

First Posted Date

Apr 9, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 1, 2012

Last Update Posted Date

Nov 2, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
length of IV catheter	Procedure	Subjects will be randomized to one of two IV catheter lengths	1.75 inch catheter length 2.5 inch catheter length

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Paul Sierzenski, MD, RDMS	Christiana Care Health Services	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Christiana Care Health Services		Newark	Delaware	19718	United States