Difficult IV Access Clinical Trial
Official title:
Peripheral Internal Jugular Vein ('Peripheral IJ') Access in Patients Identified as Difficult Intravenous Access Research Study
NCT number | NCT03063996 |
Other study ID # | A16-598 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | February 7, 2017 |
Est. completion date | June 12, 2018 |
Verified date | September 2018 |
Source | HealthPartners Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 29 |
Est. completion date | June 12, 2018 |
Est. primary completion date | June 5, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | Regions Hospital | Saint Paul | Minnesota |
Lead Sponsor | Collaborator |
---|---|
HealthPartners Institute |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | Procedural patient comfort | Pain-score assessment (10-point Likert scale) | Average 5 minutes to 1 hour post procedure |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
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