Difficult IV AccessNCT03063996
Peripheral Internal Jugular Vein ('Peripheral IJ') Access in Patients Identified as Difficult Intravenous Access
A study testing peripheral IV access procedure and Peripheral IJ access procedure in people with Difficult IV Access, run by HealthPartners Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Difficult IV Access
- What is being tested?
- peripheral IV access procedure and Peripheral IJ access procedure
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2017to 12 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Prior neck surgery
- Known blood clot in IJ vein
- Overlying infection
- Need for immediate IV access
- Provider not available for procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
This will be a randomized control trial comparing peripheral IJ to standard care of difficult access patients.
- 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.
- Nurse will contact research assistant.
- 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).
- RA will consent patient, discussing possible continuation of IV or IJ catheter insertion. If patient agrees, he/she will be enrolled in the study.
- Patient will be randomized.
- 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).
- RA will monitor procedure progress and stop time clock when access has been confirmed by study member or by nurse.
- RA will survey patient regarding pain during procedure and satisfaction.
- 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
- Being tested
- peripheral IV access procedure, Peripheral IJ access procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peripheral IV access procedureProcedure or surgery
standard of care guided IV access into peripheral vein excluding IJ
Peripheral IJ access procedureProcedure or surgery
standard of care guided IV access into IJ
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care (peripheral IV access) | Other | Patient with a history of difficult access or a patient that currently has difficult peripheral IV access. Receives: 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. Receives: Procedure: Peripheral IJ access procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total time to gain successful IV access
Time to successful IV (or IJ) access in minutes from ED arrival
Measured: ED arrival to successful venous access, up to 300 minutes
Secondary outcomes (2)
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)
Measured: Up to 2 weeks after IV placement and/or removal
Procedural patient comfort
Pain-score assessment (10-point Likert scale)
Measured: Average 5 minutes to 1 hour post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start7 Feb 2017
- Primary completion5 Jun 2018
- Study completion12 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult IV AccessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This will be a randomized control trial comparing peripheral IJ to standard care of difficult access patients.
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- HealthPartners Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Zwank, MD, Principal investigator, Regions Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03063996
- Sponsor's protocol ID
- A16-598
- Status last verified
- Sep 2018
- First submitted
- 16 Feb 2017
- Last updated
- 7 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to share individual personnel data
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Peripheral Internal Jugular Vein ('Peripheral IJ') Access in Patients Identified as Difficult Intravenous Access Research Study
- ClinicalTrials.gov ID
- NCT03063996
- Acronym / sponsor ID
- A16-598
- Conditions
- Difficult IV Access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- HealthPartners InstituteUniversity, hospital or other
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 5 Jun 2018 (actual)
- Study completion
- 12 Jun 2018 (actual)
- First posted
- 24 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
- Nurse will contact research assistant.
- 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).
- RA will consent patient, discussing possible continuation of IV or IJ catheter insertion. If patient agrees, he/she will be enrolled in the study.
- Patient will be randomized.
- 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).
- RA will monitor procedure progress and stop time clock when access has been confirmed by study member or by nurse.
- RA will survey patient regarding pain during procedure and satisfaction.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This will be a randomized control trial comparing peripheral IJ to standard care of difficult access patients.
| Arm | Type | Receives |
|---|---|---|
| Standard of Care (peripheral IV access) | Other | Procedure: peripheral IV access procedurePatient with a history of difficult access or a patient that currently has difficult peripheral IV access. |
| Peripheral IJ access | Active comparator | Procedure: Peripheral IJ access procedurePatient 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- Prior neck surgery
- Known blood clot in IJ vein
- Overlying infection
- Need for immediate IV access
- Provider not available for procedure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peripheral IV access procedurestandard of care guided IV access into peripheral vein excluding IJ | Procedure or surgery | Standard of Care (peripheral IV access) |
| Peripheral IJ access procedurestandard of care guided IV access into IJ | Procedure or surgery | Peripheral IJ access |
Primary outcome
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
2 secondary outcomes
Venous access complication
Time frame: Up to 2 weeks after IV placement and/or removal
Procedural patient comfort
Time frame: Average 5 minutes to 1 hour post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2018.
- Individual participant dataSharing planned: No. We do not plan to share individual personnel data
Related trials for Difficult IV Access
Enrolling by invitation
TruVascular Access - Ultrasound-Guided Vascular Access Study
Peripheral Venous Catheterization, Difficult Intravenous Access
Recruiting
Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered Nurses
Difficult Vein Access, Emergency Department Patients
Not yet recruiting
Ultra-Long Peripheral Catheter Versus Accelerated Seldinger Technique Long Peripheral Catheter in Difficult IV Access Patients
Difficult Intravenous Access, Adults
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Zwank, MD principal investigator
Regions Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peripheral IV access procedure and Peripheral IJ access procedure in people with Difficult IV Access, run by HealthPartners Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total time to gain successful IV access (time frame: ED arrival to successful venous access, up to 300 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Sep 2018.