Vascular Access ComplicationNCT01937195
AccuCath™ Intravenous (IV) Device Used by Vascular Access Team (VAT)
A study testing AccuCath Intravenous Catheter System 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 (PIV) 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 Intravenous Catheter System
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2013to Nov 2014
- 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 > 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 PIV 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 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
Evangelical Community Hospital
Lewisburg, Pennsylvania, 17837
About this study
Official title: A Prospective, Randomized, Controlled, Multicenter Comparison Between the AccuCath™ Intravenous Catheter System With Retractable Coiled Tip Guidewire and Conventional Peripheral Intravenous Catheters With a Vascular Access Team
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (PIV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user satisfaction compared to Conventional IV Catheters.
Read the detailed description
Phase One is designed as a one-arm prospective study to compare patients using the AccuCath™ Intravenous Catheter System to the results found in literature. Phase Two is designed as a two-arm prospective randomized controlled study comparing the AccuCath™ Intravenous Catheter System to conventional PIV catheters. This study site will be completing Phase One only.
- Conditions
- Vascular Access Complication
- Being tested
- AccuCath Intravenous 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, 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 Intravenous Catheter SystemDevice
AccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters.
| Study group | Role | What they receive |
|---|---|---|
| AccuCath Intravenous Catheter System | Experimental | AccuCath Intravenous Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Receives: Device: AccuCath Intravenous Catheter System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt
The primary endpoint is to observe the rate of first attempt success (where the inserter only pierces the skin once and successfully places the PIV catheter in the vein) in patients requiring PIV access.
Measured: Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure
Secondary outcomes (6)
Percentage of Patients With Complications of Peripheral IV Therapy
Will measure the percentage of patients with (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: Study exit/at catheter removal expected to be up to 7 days post placement
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 (generally up to 7 days).
Measured: Study exit/at catheter removal expected to be up to 7 days post placement
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 expected to be up to 7 days post placement
Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Insertion
Patients were surveyed regarding satisfaction with catheter insertion with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.
Measured: Baseline at catheter insertion in the first 3-15 minutes after procedure
Number of Participants Experiencing Adverse Events
Will measure the number and severity of adverse events associated with peripheral IV initiation and indwelling catheter time up to 7 days. Adverse events are anticipated complications of IV therapy.
Measured: baseline, and up to catheter removal expected to be no more than 7 days post placement
Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Removal
Patients were surveyed regarding satisfaction with catheter performance with a 5-point Likert scale (1 the lowest, 5 the highest). Satisfaction was defined as a score of 3 to 5.
Measured: At catheter removal, which is expected to be up to 7 days post placement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2013 (estimated)
- Study startApr 2013
- Primary completionJul 2014
- Study completionNov 2014
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.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Norman R Anderson, RN, Principal investigator, Evangelical Community Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01937195
- Sponsor's protocol ID
- VPW-STP-00002
- Status last verified
- Mar 2017
- First submitted
- 15 Apr 2013
- Last updated
- 20 Apr 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Anderson NR. Influencing Patient Satisfaction Scores: Prospective One-Arm Study of a Novel Intravenous Catheter System With Retractable Coiled-Tip Guidewire Compared With Published Literature for Conventional Peripheral Intravenous Catheters. J Infus Nurs. 2016 Jul-Aug;39(4):201-9. doi: 10.1097/NAN.0000000000000173.
PubMed 27379678
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Controlled, Multicenter Comparison Between the AccuCath™ Intravenous Catheter System With Retractable Coiled Tip Guidewire and Conventional Peripheral Intravenous Catheters With a Vascular Access Team
- ClinicalTrials.gov ID
- NCT01937195
- Acronym / sponsor ID
- VPW-STP-00002
- 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
- 95 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Apr 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 9 Sep 2013 (estimated)
- Results
- Posted 20 Apr 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 (PIV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user satisfaction compared to Conventional IV Catheters.
Detailed description
Phase One is designed as a one-arm prospective study to compare patients using the AccuCath™ Intravenous Catheter System to the results found in literature. Phase Two is designed as a two-arm prospective randomized controlled study comparing the AccuCath™ Intravenous Catheter System to conventional PIV catheters. This study site will be completing Phase One only.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AccuCath Intravenous Catheter System | Experimental | Device: AccuCath Intravenous Catheter SystemAccuCath Intravenous Catheter System 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 > 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 PIV 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 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 Intravenous Catheter SystemAccuCath IV Catheter System will be used for IV therapy during inpatient stay. Intervention includes vascular access, fluid infusion, and blood sample removal. Results will be compared to published literature for conventional IV catheters. | Device | AccuCath Intravenous Catheter System |
Primary outcome
Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt
Time frame: Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure
The primary endpoint is to observe the rate of first attempt success (where the inserter only pierces the skin once and successfully places the PIV catheter in the vein) in patients requiring PIV access.
6 secondary outcomes
Percentage of Patients With Complications of Peripheral IV Therapy
Time frame: Study exit/at catheter removal expected to be up to 7 days post placement
Completion of IV Therapy
Time frame: Study exit/at catheter removal expected to be up to 7 days post placement
Catheter Dwell Time
Time frame: Study exit/at catheter removal expected to be up to 7 days post placement
Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Insertion
Time frame: Baseline at catheter insertion in the first 3-15 minutes after procedure
Number of Participants Experiencing Adverse Events
Time frame: baseline, and up to catheter removal expected to be no more than 7 days post placement
Percentage of Patients Who Identified as "Satisfied" With Catheter Performance at Catheter Removal
Time frame: At catheter removal, which is expected to be up to 7 days post placement
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 27379678Anderson NR. Influencing Patient Satisfaction Scores: Prospective One-Arm Study of a Novel Intravenous Catheter System With Retractable Coiled-Tip Guidewire Compared With Published Literature for Conventional Peripheral Intravenous Catheters. J Infus Nurs. 2016 Jul-Aug;39(4):201-9. doi: 10.1097/NAN.0000000000000173.
- 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.
Norman R Anderson, RN principal investigator
Evangelical Community 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 AccuCath Intravenous Catheter System 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 20 Apr 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 20 Apr 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?
Percentage of Participants With Successfully Inserted Peripheral IV Catheter Placement on First Attempt (time frame: Baseline/at catheter placement, usually 3-15 minutes initial during insertion procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01937195, which also lists 1 linked publication.
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 20 Apr 2017.