Difficult Peripheral IV AccessNCT02422472
Comparison of Ultrasound Guided Peripheral IV Placement With and Without Use of a Guidewire
A study testing Ultrasound guided peripheral IV placement in people with Difficult Peripheral IV Access, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
The purpose of this study is to compare ultrasound guided peripheral IV placement with and without the use of a guidewire. Patients in the Emergency Department with difficult peripheral IV access (as defined by 2 failed attempts by nursing staff) will be consented and randomized to standard ultrasound guided… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Difficult Peripheral IV Access
- What is being tested?
- Ultrasound guided peripheral IV placement
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Difficult peripheral IV access (2 failed attempts by nursing staff)
- Prior history of difficult IV access and patient request for ultrasound guided IV
Who cannot join
- Need for emergent access or central venous access
- Inability to provide informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
The purpose of this study is to compare ultrasound guided peripheral IV placement with and without the use of a guidewire. Patients in the Emergency Department with difficult peripheral IV access (as defined by 2 failed attempts by nursing staff) will be consented and randomized to standard ultrasound guided peripheral IV placement or ultrasound guided peripheral IV placement with modified seldinger technique using a guidewire.
- Conditions
- Difficult Peripheral IV Access
- Being tested
- Ultrasound guided peripheral IV placement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided peripheral IV placementDevice
Accucath™ 20 Gax 5.7cm catheter
| Study group | Role | What they receive |
|---|---|---|
| Standard | No intervention | Standard of care ultrasound guided peripheral IV placement |
| Experimental | Experimental | Ultrasound guided peripheral IV placement with the use of a guidewire Receives: Device: Ultrasound guided peripheral IV placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
First attempt success rate
First attempt success is defined as ability to place and use the catheter after only one attempt and will be reported by study staff.
Measured: 60 minutes
Secondary outcomes (3)
Overall success rate
Overall success is defined as ability to place and use the catheter (after 2 or fewer attempts) and will be reported by study staff.
Measured: 60 minutes
Number of skin punctures
Number of skin punctures will be recorded by study staff.
Measured: 60 minutes
Complications including hematoma, IV infiltration, catheter dislodge
Patients will be monitored for complications of IV placement by study staff
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2015 (estimated)
- Study startJun 2015
- Primary completionJun 2018
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Difficult Peripheral IV AccessStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heidi Kimberly, Brigham and Women's Hospital
- Investigators
- Heidi Kimberly, MD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02422472
- Sponsor's protocol ID
- 2015P000073
- Status last verified
- Jan 2019
- First submitted
- 14 Apr 2015
- Last updated
- 16 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Ultrasound Guided Peripheral IV Placement With and Without Use of a Guidewire
- ClinicalTrials.gov ID
- NCT02422472
- Acronym / sponsor ID
- 2015P000073
- Conditions
- Difficult Peripheral IV Access
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- Jun 2015
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 21 Apr 2015 (estimated)
- 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 purpose of this study is to compare ultrasound guided peripheral IV placement with and without the use of a guidewire. Patients in the Emergency Department with difficult peripheral IV access (as defined by 2 failed attempts by nursing staff) will be consented and randomized to standard ultrasound guided peripheral IV placement or ultrasound guided peripheral IV placement with modified seldinger technique using a guidewire.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard | No intervention | –Standard of care ultrasound guided peripheral IV placement |
| Experimental | Experimental | Device: Ultrasound guided peripheral IV placementUltrasound guided peripheral IV placement with the use of a guidewire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Difficult peripheral IV access (2 failed attempts by nursing staff)
- Prior history of difficult IV access and patient request for ultrasound guided IV
Key exclusion criteria (2 listed)
- Need for emergent access or central venous access
- Inability to provide informed consent
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 |
|---|---|---|
| Ultrasound guided peripheral IV placementAccucath™ 20 Gax 5.7cm catheter | Device | Experimental |
Primary outcome
First attempt success rate
Time frame: 60 minutes
First attempt success is defined as ability to place and use the catheter after only one attempt and will be reported by study staff.
3 secondary outcomes
Overall success rate
Time frame: 60 minutes
Number of skin punctures
Time frame: 60 minutes
Complications including hematoma, IV infiltration, catheter dislodge
Time frame: 3 days
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 16 Jan 2019.
- Individual participant dataSharing planned: No
Related trials for Difficult Peripheral 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.
Heidi Kimberly, MD principal investigator
Brigham and Women's 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 Ultrasound guided peripheral IV placement in people with Difficult Peripheral IV Access, run by Brigham and Women's Hospital 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 2 inclusion and 2 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 16 Jan 2019. 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?
First attempt success rate (time frame: 60 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 16 Jan 2019.