Vascular Access ComplicationNCT01943474
AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use
A study testing AccuCath IV Catheter Device and Conventional IV Catheter Device in people with Vascular Access Complication, 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 intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user satisfaction compared to conventional IV catheters. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Vascular Access Complication
- What is being tested?
- AccuCath IV Catheter Device and Conventional IV Catheter Device
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Oct 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age ≥ 18 years or ≤ 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 inpatient unit.
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 principal investigator [PI]);
- Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating.
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Case Medical Center
Cleveland, Ohio, 44106
About this study
Official title: The AccuCath Intravenous Catheter System With Retractable Coiled Tip Guidewire and Conventional Peripheral Intravenous Catheters: A Prospective, Randomized, Controlled Comparison by General Hospital Nursing Staff
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user 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 and catheter device compared with conventional needle/catheter vascular access devices, in terms of first stick success rates, dwell time, device-related vascular complications and 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, higher completion of therapy, fewer complications, longer dwell times and higher user satisfaction compared to conventional intravenous catheters.
- Conditions
- Vascular Access Complication
- Being tested
- AccuCath IV Catheter Device, Conventional IV Catheter Device
- 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, Complication Rates for IV Catheters, Average Dwell Time for IV Catheters, 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 DeviceDevice
Also called Rapid Intravascular Start System (RIVS), AccuCath System, AccuCath IV device, AccuCath
Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
Conventional IV Catheter DeviceDevice
Also called Insyte Autoguard, Insyte Autoguard PIV, Insyte Autoguard IV Catheter, Insyte Autoguard IV device
Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
| Study group | Role | What they receive |
|---|---|---|
| AccuCath IV Catheter Device | Experimental | AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal Receives: Device: AccuCath IV Catheter Device |
| Conventional IV Catheter Device | Active comparator | Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal Receives: Device: Conventional IV Catheter Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Attempt Success Rate With Peripheral IV Catheter Placement
The primary outcomes measure is to observe first attempt success rate in patients requiring peripheral IV access by documenting the number of catheter attempts (each new catheter) required to complete successful peripheral IV placement.
Measured: At catheter placement, an expected average of 10 minutes
Secondary outcomes (8)
Completion of IV Therapy
Completion of IV therapy will measure whether the catheter remained in place for the duration of required intravenous treatment during the inpatient stay (~ up to 7 days).
Measured: Study exit/At catheter removal (~ up to 7 days)
Complications of Peripheral IV Therapy
Will measure the rate of observed (anticipated) complications of IV therapy - infection, occlusion, infiltration, extravasation, phlebitis, dislodgement, leaking/bleeding at site, patient complaints of pain without other identifiable cause, and other (~ up to 7 days).
Measured: From during to post IV catheter placement up to study exit (~ up to 7 days)
Catheter Dwell Time
Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) ~ up to 7 days.
Measured: Study Exit/At catheter removal (~ up to 7 days)
Patient Satisfaction At Insertion
Will survey patients regarding satisfaction with catheter insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.
Measured: At catheter insertion, initial 3-15 minutes after insertion procedure completed.
Clinician Satisfaction
Will measure clinician satisfaction of the AccuCath IV device via a 5 point Likert scale survey based on overall catheter performance during experience and use. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.
Measured: At completion of study after all patients have been enrolled (approximately 6 months from study initiation)
Adverse Events
Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time (anticipated to be similar in both groups). This period will generally include up to 7 days of total IV dwell time.
Measured: During and post IV catheter placement until study exit (maximum of 6 months).
Patient Satisfaction Comfort Comparison
Patient satisfaction with comfort of IV insertion compared to most recent previous IV insertion using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.
Measured: Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure.
Patient Satisfaction With Overall IV Performance
Patient satisfaction with overall IV performance at IV removal using a 5-point Likert scale. 5 - Very satisfied, 4 - Somewhat satisfied, 3 - Neutral, 2 - Somewhat unsatisfied, 1 - Very unsatisfied. 3 and above are considered positive. 2 and below are considered negative.
Measured: At IV removal (usually after 1-7 days of IV dwell time)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2013
- Study completionOct 2013
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 ComplicationStudies 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
- 248 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- James Rowbottom, MD, Principal investigator, University Hospitals Cleveland Medical CenterBette Idemoto, PhD, RN, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01943474
- Sponsor's protocol ID
- DDVP-001/VPW-STP-00004
- Status last verified
- Jan 2017
- First submitted
- 8 Apr 2013
- Last updated
- 9 Mar 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 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The AccuCath Intravenous Catheter System With Retractable Coiled Tip Guidewire and Conventional Peripheral Intravenous Catheters: A Prospective, Randomized, Controlled Comparison by General Hospital Nursing Staff
- ClinicalTrials.gov ID
- NCT01943474
- Acronym / sponsor ID
- DDVP-001/VPW-STP-00004
- Conditions
- Vascular Access Complication
- 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, Complication Rates for IV Catheters, Average Dwell Time for IV Catheters
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Posted 9 Mar 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 intravenous (IV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user 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 and catheter device compared with conventional needle/catheter vascular access devices, in terms of first stick success rates, dwell time, device-related vascular complications and 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, higher completion of therapy, fewer complications, longer dwell times and higher user satisfaction compared to conventional intravenous catheters.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AccuCath IV Catheter Device | Experimental | Device: AccuCath IV Catheter DeviceAccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal |
| Conventional IV Catheter Device | Active comparator | Device: Conventional IV Catheter DeviceConventional IV catheter (current catheter) will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female, age ≥ 18 years or ≤ 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 inpatient unit.
Key exclusion criteria (5 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 principal investigator [PI]);
- Females who are pregnant, planning to become pregnant within 3 months of the procedure, or lactating.
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 DeviceAlso: Rapid Intravascular Start System (RIVS), AccuCath System, AccuCath IV device, AccuCathVascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples. | Device | AccuCath IV Catheter Device |
| Conventional IV Catheter DeviceAlso: Insyte Autoguard, Insyte Autoguard PIV, Insyte Autoguard IV Catheter, Insyte Autoguard IV deviceVascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples. | Device | Conventional IV Catheter Device |
Primary outcome
First Attempt Success Rate With Peripheral IV Catheter Placement
Time frame: At catheter placement, an expected average of 10 minutes
The primary outcomes measure is to observe first attempt success rate in patients requiring peripheral IV access by documenting the number of catheter attempts (each new catheter) required to complete successful peripheral IV placement.
8 secondary outcomes
Completion of IV Therapy
Time frame: Study exit/At catheter removal (~ up to 7 days)
Complications of Peripheral IV Therapy
Time frame: From during to post IV catheter placement up to study exit (~ up to 7 days)
Catheter Dwell Time
Time frame: Study Exit/At catheter removal (~ up to 7 days)
Patient Satisfaction At Insertion
Time frame: At catheter insertion, initial 3-15 minutes after insertion procedure completed.
Clinician Satisfaction
Time frame: At completion of study after all patients have been enrolled (approximately 6 months from study initiation)
Adverse Events
Time frame: During and post IV catheter placement until study exit (maximum of 6 months).
Patient Satisfaction Comfort Comparison
Time frame: Immediately after catheter insertion, within the first 3-15 minutes of insertion procedure.
Patient Satisfaction With Overall IV Performance
Time frame: At IV removal (usually after 1-7 days of IV dwell time)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
James Rowbottom, MD principal investigator
University Hospitals Cleveland Medical Center
Bette Idemoto, PhD, RN principal investigator
University Hospitals Cleveland Medical Center
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 Device and Conventional IV Catheter Device in people with Vascular Access Complication, 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 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 9 Mar 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 Mar 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 Catheter Placement (time frame: At catheter placement, an expected average of 10 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 Mar 2017.