Peripheral Internal Jugular Vein ('Peripheral IJ') Access in Patients Identified as Difficult Intravenous Access

NCT03063996 | Completed

• 1 other identifier: A16-598
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this study is to determine if the insertion of a peripheral Internal Jugular (IJ) catheter is faster than a standard of care intravenous (IV)access in patients with difficult access. The secondary aims of this study examine patient discomfort between standard IV insertion vs. peripheral IV insertion as well as a comparison of complication rates between the two methods of insertion. Support for the peripheral IV procedure could provide an option for the thousands of Emergency Department (ED) patients who daily encounter the situation of difficult IV access and the numerous needle pokes that accompany it. Using this procedure may result in greater patient satisfaction and reduced complication rates.

Conditions

Difficult IV Access

Outcome Measures

Primary Outcomes (1)

• Total time to gain successful IV access

  Time to successful IV (or IJ) access in minutes from ED arrival

  ED arrival to successful venous access, up to 300 minutes

Secondary Outcomes (2)

• Venous access complication

  Up to 2 weeks after IV placement and/or removal

• Procedural patient comfort

  Average 5 minutes to 1 hour post procedure

Study Arms (2)

Standard of Care (peripheral IV access)

OTHER

Patient with a history of difficult access or a patient that currently has difficult peripheral IV access.

Procedure: peripheral IV access procedure

Peripheral IJ access

ACTIVE COMPARATOR

Patient with a history of difficult access or a patient that currently has difficult peripheral IV access and is randomized into the group that gets peripheral IJ access.

Procedure: Peripheral IJ access procedure

Interventions

peripheral IV access procedure PROCEDURE

standard of care guided IV access into peripheral vein excluding IJ

Standard of Care (peripheral IV access)

Peripheral IJ access procedure PROCEDURE

standard of care guided IV access into IJ

Peripheral IJ access

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Emergency Department patient
• Need for IV access
• Difficult access as determined by nurse based on current challenges with IV access or in discussion with patient regarding past experience
• Patient in stable condition as determined by treating team
• English speaking
• Ability to consent
• Age ≥ 18 years

You may not qualify if:

• Prior neck surgery
• Known blood clot in IJ vein
• Overlying infection
• Need for immediate IV access
• Provider not available for procedure

Sponsors & Collaborators

• HealthPartners Institute: lead

Study Sites (1)

Regions Hospital

Saint Paul, Minnesota, 55101, United States

Location

Study Officials

• Michael Zwank, MD

  Regions Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This will be a randomized control trial comparing peripheral IJ to standard care of difficult access patients.

Study Record Dates

• First Submitted: February 16, 2017
• First Posted: February 24, 2017
• Study Start: February 7, 2017
• Primary Completion: June 5, 2018
• Study Completion: June 12, 2018
• Last Updated: September 7, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)