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

NCT ID: NCT03063996

Last Updated: 2018-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-07
• Study Completion Date: 2018-06-12

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.

Detailed Description

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

1. Patients will be identified by nurses as having difficult IV access. This can be determined based on past history or immediate experience. In other words, while a nurse is caring for a patient, s/he might notice that the patient looks to have difficult veins for an IV and may ask the patient 'Are you a hard stick?'. On the other hand, the nurse may fail at a number of attempts at placing an IV. In both of the cases, the patients can be determined to have difficult access and the nurse will have the option to contact the research assistant or continue with current attempts.

2. Nurse will contact research assistant.

3. Research assistant (RA) will determine if the patient is being cared for by an MD with appropriate experience for placing the peripheral IJ (attending, second or third year ED resident).

4. RA will consent patient, discussing possible continuation of IV or IJ catheter insertion. If patient agrees, he/she will be enrolled in the study.

5. Patient will be randomized.

6. Time clock will be started by RA when nurse or study member (attending physician, second or third year resident) start the procedure (IV or IJ).

7. RA will monitor procedure progress and stop time clock when access has been confirmed by study member or by nurse.

8. RA will survey patient regarding pain during procedure and satisfaction.

9. Patient chart will be queried at the completion of ED visit or hospitalization for complications. Chart will be queried again at two weeks to evaluate for any return visit complication.

Catheters will be placed by attending physicians and residents (2nd and 3rd years) with experience placing ultrasound guided internal jugular central venous catheters. Because the procedure is identical to the first step of placing an IJ Central Venous Catheter, there is no special training needed for the procedure itself. A video will be created and viewed by all placing the catheters to show the specifics so that there is standardization between individuals.

Attempts to place the peripheral IJ will be limited to two. If not successful after two attempts, the patient will return to 'standard care' and the treatment team will decide on further directions such as ultrasound guided peripheral IV or central venous line.

Conditions

Difficult IV Access

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Standard of Care (peripheral IV access)

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

Group Type: OTHER

peripheral IV access procedure

Intervention Type: PROCEDURE

standard of care guided IV access into peripheral vein excluding IJ

Peripheral IJ access

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.

Group Type: ACTIVE_COMPARATOR

Peripheral IJ access procedure

Intervention Type: PROCEDURE

standard of care guided IV access into IJ

Interventions

peripheral IV access procedure

standard of care guided IV access into peripheral vein excluding IJ

Intervention Type: PROCEDURE

Peripheral IJ access procedure

standard of care guided IV access into IJ

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

1. Emergency Department patient

2. Need for IV access

3. Difficult access as determined by nurse based on current challenges with IV access or in discussion with patient regarding past experience

4. Patient in stable condition as determined by treating team

5. English speaking

6. Ability to consent

7. Age ≥ 18 years

Exclusion Criteria

1. Prior neck surgery

2. Known blood clot in IJ vein

3. Overlying infection

4. Need for immediate IV access

5. Provider not available for procedure

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

HealthPartners Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michael Zwank, MD

Role: PRINCIPAL_INVESTIGATOR

Regions Hospital

Locations

Regions Hospital

Saint Paul, Minnesota, United States

Countries

United States

Other Identifiers

A16-598

Identifier Type: -

Identifier Source: org_study_id