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

September 5, 2018 updated by: HealthPartners Institute

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
29

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Total time to gain successful IV access
Time Frame: ED arrival to successful venous access, up to 300 minutes
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Venous access complication
Time Frame: Up to 2 weeks after IV placement and/or removal
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
Time Frame: Average 5 minutes to 1 hour post procedure
Pain-score assessment (10-point Likert scale)
Average 5 minutes to 1 hour post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
HealthPartners Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Zwank, MD, Regions Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 5, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 12, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 16, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 21, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 24, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 7, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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