NCT01439113

Brief Summary

The placement of peripheral intravenous lines (IVs) is central to the treatment of patients in the emergency department (ED). The procedure is used for phlebotomy and administration of a variety of therapeutic medications and intravenous fluids. This procedure is standard of care, and IVs are routinely placed by experienced emergency nurses. Occasionally, the nurse will have difficulty placing an IV line. The most common reason for this is an underlying medical condition, such as diabetes, severe peripheral vascular disease, obesity, or a history of intravenous drug use. When a nurse is unable to place an IV, the options are:

  1. 1.Ask another nurse to attempt the line placement
  2. 2.Ask a physician to establish access, which usually involves placement of a central venous catheter, a time-consuming procedure with higher risk of infection than a peripheral line.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2010

Geographic Reach
1 country

2 active sites

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, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 21, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2011

Completed
Last Updated

March 28, 2023

Status Verified

March 1, 2023

Enrollment Period

1 year

First QC Date

September 21, 2011

Last Update Submit

March 27, 2023

Conditions

Keywords

Ultrasound, Difficult access

Outcome Measures

Primary Outcomes (1)

  • Need for intervention by a physician to obtain IV access

    The number of times a physician needs to intervene to place an IV when the nurse confronts a patient with difficult IV access

    1 year

Secondary Outcomes (3)

  • Time to IV placement

    1 year

  • Patient pain perception

    1 year

  • Number of skin punctures required to obtain IV access

    1 year

Study Arms (2)

Standard of care

NO INTERVENTION

In this arm, patients who have difficult IV access will undergo the standard of care. The options include a) repeated attempts by a primary nurse, b) new attempts by a second nurse, c) central line placement by a physician, d) intraosseous line placement by a physician, e) physician use of ultrasound for peripheral IV placement

Ultrasound-guided IV

EXPERIMENTAL

In this arm, the emergency nurse will apply the ultrasound machine to locate and cannulate a patient's peripheral veins

Procedure: Ultrasound guided IV placement

Interventions

The nurse will use the emergency department's ultrasound machine to locate peripheral veins and then cannulate the vessel under ultrasound guidance.

Ultrasound-guided IV

Eligibility Criteria

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

You may qualify if:

  • Any patient in whom IV access is indicated but either a) have a history of difficult IV access (either by self-report or by knowledge of the nurse or physician) or in whom two unsuccessful attempts (defined as skin punctures) have failed.

You may not qualify if:

  • Patients will be excluded who are intoxicated, have acute psychiatric illness with exacerbation, who are prisoners, who cannot provide consent for themselves and who do not speak English.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Baystate Medical Center

Springfield, Massachusetts, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 21, 2011

First Posted

September 22, 2011

Study Start

June 1, 2010

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

March 28, 2023

Record last verified: 2023-03

Locations