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

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

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.

Study Overview

• Status: Completed
• Conditions: Difficult IV Access
• Intervention / Treatment: Procedure: peripheral IV access procedure; Procedure: Peripheral IJ access procedure

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.

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Saint Paul, Minnesota, United States, 55101
      • Regions Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard of Care (peripheral IV access); Patient with a history of difficult access or a patient that currently has difficult peripheral IV access.	Procedure: peripheral IV access procedure; standard of care guided IV access into peripheral vein excluding IJ
Active Comparator: 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.	Procedure: Peripheral IJ access procedure; standard of care guided IV access into IJ

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Venous access complication	Variables: Immediate Complications -noted at time of procedure (hematoma, arterial puncture, pneumothorax, infection, line failure) Delayed complications - noted at time of discharge OR at 2 week chart follow-up (hematoma, pneumothorax, infection, line failure)	Up to 2 weeks after IV placement and/or removal
Procedural patient comfort	Pain-score assessment (10-point Likert scale)	Average 5 minutes to 1 hour post procedure

Collaborators and Investigators

• Sponsor: HealthPartners Institute
• Investigators: Principal Investigator: Michael Zwank, MD, Regions Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 7, 2017
• Primary Completion (Actual): June 5, 2018
• Study Completion (Actual): June 12, 2018

Study Registration Dates

• First Submitted: February 16, 2017
• First Submitted That Met QC Criteria: February 21, 2017
• First Posted (Actual): February 24, 2017

Study Record Updates

• Last Update Posted (Actual): September 7, 2018
• Last Update Submitted That Met QC Criteria: September 5, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: A16-598

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: We do not plan to share individual personnel data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No