Vascular Access ComplicationsNCT01940354
Comparison of AccuCath IV Catheter and Conventional IV Catheter in Interventional Radiology
A study testing AccuCath IV Catheter System and Conventional IV Catheter System in people with Vascular Access Complications, run by C. R. Bard at 1 site in United States.
Trial summary
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters. Read more about this study
- Who is it for?
- Ages 18 to 89 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Access Complications
- What is being tested?
- AccuCath IV Catheter System and Conventional IV Catheter System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Mar 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 89 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, age > or equal to 18 years or < or equal to 89 years old;
- Capable and willing to give informed consent;
- English speaking;
- Acceptable candidate for an elective, non-emergent peripheral intravenous (PIV) catheter placement as determined by ordering physician;
- Admitted to study area.
Who cannot join
- Male or female, < 18 years old or > 89 years old;
- Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);
- Previous venous grafts or surgery at the target vessel access site;
- Currently involved in other investigational clinical trials (unless permission is granted by other study PI).
Trial locations and contacts
1 site in 1 country.
United States1 site
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
About this study
Official title: A Prospective, Randomized, Controlled Comparison of First Attempt Success Between the AccuCath Intravenous System With Retractable Coiled Tip Guide Wire and Conventional Peripheral Intravenous Catheters With Interventional Radiology Nurses
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters.
Read the detailed description
This study is designed to evaluate user/physician preference as it relates to use of a 510(k) cleared vascular access peripheral IV catheter device compared with peripheral IV conventional needle/catheter devices, in terms of first stick success rates, adverse events and overall user and patient satisfaction. As noted above, the study is designed to formally test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement and higher user and patient satisfaction compared to Conventional IV Catheters.
- Conditions
- Vascular Access Complications
- Being tested
- AccuCath IV Catheter System, Conventional IV Catheter System
- Keywords
- IV Catheter comparison, AccuCath versus Conventional IV Catheters, IV Catheter Study, IV Catheter User Preference Comparison, First Attempt Success Rate for IV Catheters, AccuCath Device Performance, Patient Satisfaction with IV Catheters, Clinician Satisfaction with AccuCath Device Performance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuCath IV Catheter SystemDevice
Also called Rapid Intravascular Start System (RIVS), AccuCath System
Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
Conventional IV Catheter SystemDevice
Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples
| Study group | Role | What they receive |
|---|---|---|
| Vascular access via study device | Experimental | AccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal. Receives: Device: AccuCath IV Catheter System |
| Vascular access via control device | Active comparator | Conventional IV Catheter System (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal. Receives: Device: Conventional IV Catheter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement
Measured: Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutes
Secondary outcomes (2)
Patient Satisfaction Upon Successful PIV Placement
Patient Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: 5 - Very Comfortable, 4 - Somewhat Comfortable, 3 - Neutral, 2- Somewhat Uncomfortable, 1 - Very Uncomfortable
Measured: Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes
Clinician Satisfaction Upon Successful PIV Placement
Clinician Satisfaction was measured at initial PIV placement using a 5 Point Likert Scale: "How easy was the AccuCath™ System to use in comparison to the current catheter?" 5 - Easier to Use 4 - Somewhat Easier to Use 3 - Neutral 2 - Somewhat Difficult to Use
1 - Very Difficult to Use
Measured: Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionNov 2013
- Study completionMar 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vascular Access ComplicationsStudies of the same condition, open and under way.
- More trials run by C. R. BardThe 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
- 220 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Scott O Trerotola, BA, MD, Principal investigator, University of PennsylvaniaWilliam Stavropoulos, MD, Principal investigator, Hosptial of the University of PennsylvaniaSuzanne Sweeney, RN, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01940354
- Sponsor's protocol ID
- VPW-STP-00003
- Status last verified
- Oct 2017
- First submitted
- 3 Sep 2013
- Last updated
- 9 Nov 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled Comparison of First Attempt Success Between the AccuCath Intravenous System With Retractable Coiled Tip Guide Wire and Conventional Peripheral Intravenous Catheters With Interventional Radiology Nurses
- ClinicalTrials.gov ID
- NCT01940354
- Acronym / sponsor ID
- VPW-STP-00003
- Conditions
- Vascular Access Complications
- Keywords
- IV Catheter comparison, AccuCath versus Conventional IV Catheters, IV Catheter Study, IV Catheter User Preference Comparison, First Attempt Success Rate for IV Catheters, AccuCath Device Performance, Patient Satisfaction with IV Catheters, Clinician Satisfaction with AccuCath Device Performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 220 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Aug 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 12 Sep 2013 (estimated)
- Results
- Posted 9 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral IV placement and higher clinician and patient satisfaction compared to Conventional IV Catheters.
Detailed description
This study is designed to evaluate user/physician preference as it relates to use of a 510(k) cleared vascular access peripheral IV catheter device compared with peripheral IV conventional needle/catheter devices, in terms of first stick success rates, adverse events and overall user and patient satisfaction. As noted above, the study is designed to formally test the hypothesis that the AccuCath™ System will exhibit superiority in terms of the rate of successful first attempt peripheral IV placement and higher user and patient satisfaction compared to Conventional IV Catheters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vascular access via study device | Experimental | Device: AccuCath IV Catheter SystemAccuCath IV Catheter System will be used for IV therapy during interventional radiology procedure. Intervention includes vascular access, fluid infusion, and blood sample removal. |
| Vascular access via control device | Active comparator | Device: Conventional IV Catheter SystemConventional IV Catheter System (current catheter) will be used for IV therapy during interventional radiology procedure. Interventions include vascular access, administration of fluids, and blood sample removal. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
Key exclusion criteria (4 listed)
- Male or female, < 18 years old or > 89 years old;
- Requirement for emergent IV placement (patient's condition would be compromised if there is a delay in IV placement);
- Previous venous grafts or surgery at the target vessel access site;
- Currently involved in other investigational clinical trials (unless permission is granted by other study PI).
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 |
|---|---|---|
| AccuCath IV Catheter SystemAlso: Rapid Intravascular Start System (RIVS), AccuCath SystemVascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples. | Device | Vascular access via study device |
| Conventional IV Catheter SystemVascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples | Device | Vascular access via control device |
Primary outcome
First Attempt Success Rate With Peripheral IV (PIV) Catheter Placement
Time frame: Baseline/at catheter placement, PIV placement duration ranges from 3-15 minutes
2 secondary outcomes
Patient Satisfaction Upon Successful PIV Placement
Time frame: Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes
Clinician Satisfaction Upon Successful PIV Placement
Time frame: Baseline/at catheter placement; PIV placement duration ranges from 3-15 minutes
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Vascular Access Complications
Active, not recruiting
Compassionate-Use of 4% T-EDTA Lock Solution for Central Venous Lines of Pediatric PN Patients
Central Line Complication, Central Line-associated Bloodstream Infection (CLABSI)
Not yet recruiting
Impact of a Long Peripheral Venous Catheter Protocol in Pediatric and Neonatal Care
Vascular Access Devices, Vascular Access
RecruitingObservational study
Mobilisation After Endovascular Stroke Treatment
Stroke, Acute Ischemic Stroke
RecruitingPhase 2
The Cancer Connected Access and Remote Expertise Beyond Walls Program to Provide In-Home Cancer Treatment and Improve Treatment Satisfaction in Cancer Patients Living in the Florida Panhandle and Surrounding Areas
Amyloidosis, Basal Cell Carcinoma
Recruiting
ACCESS 2: AI for pediatriC diabetiC Eye examS Study 2
Type 1 Diabetes, Type 2 Diabetes
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.
Scott O Trerotola, BA, MD principal investigator
University of Pennsylvania
William Stavropoulos, MD principal investigator
Hosptial of the University of Pennsylvania
Suzanne Sweeney, RN principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AccuCath IV Catheter System and Conventional IV Catheter System in people with Vascular Access Complications, run by C. R. Bard 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 5 inclusion and 4 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 9 Nov 2017. 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?
Yes. Results are posted in the registry (first posted 9 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 With Peripheral IV (PIV) Catheter Placement (time frame: Baseline/at catheter placement, PIV placement duration ranges from 3-15 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 9 Nov 2017.