NCT02422472

Brief Summary

The purpose of this study is to compare ultrasound guided peripheral IV placement with and without the use of a guidewire. Patients in the Emergency Department with difficult peripheral IV access (as defined by 2 failed attempts by nursing staff) will be consented and randomized to standard ultrasound guided peripheral IV placement or ultrasound guided peripheral IV placement with modified seldinger technique using a guidewire.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2015

Typical duration 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

First Submitted

Initial submission to the registry

April 14, 2015

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

June 1, 2015

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

January 16, 2019

Status Verified

January 1, 2019

Enrollment Period

3 years

First QC Date

April 14, 2015

Last Update Submit

January 14, 2019

Conditions

Difficult Peripheral IV Access

Outcome Measures

Primary Outcomes (1)

  • First attempt success rate

    First attempt success is defined as ability to place and use the catheter after only one attempt and will be reported by study staff.

    60 minutes

Secondary Outcomes (3)

  • Overall success rate

    60 minutes

  • Number of skin punctures

    60 minutes

  • Complications including hematoma, IV infiltration, catheter dislodge

    3 days

Study Arms (2)

Standard

NO INTERVENTION

Standard of care ultrasound guided peripheral IV placement

Experimental

EXPERIMENTAL

Ultrasound guided peripheral IV placement with the use of a guidewire

Device: Ultrasound guided peripheral IV placement

Interventions

Ultrasound guided peripheral IV placementDEVICE

Accucath™ 20 Gax 5.7cm catheter

Experimental

Eligibility Criteria

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

You may qualify if:

  • Difficult peripheral IV access (2 failed attempts by nursing staff)
  • Prior history of difficult IV access and patient request for ultrasound guided IV

You may not qualify if:

  • Need for emergent access or central venous access
  • Inability to provide informed consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Study Officials

  • Heidi Kimberly, MD

    Brigham and Women's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Physician Emergency Medicine Brigham and Women's Hospital, Instructor in Emergency Medicine Harvard Medical School

Study Record Dates

First Submitted

April 14, 2015

First Posted

April 21, 2015

Study Start

June 1, 2015

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

January 16, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)