- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01943474
AccuCath Guidewire Intravenous (IV) Device Versus Conventional IV Catheter In General Nursing Use
January 18, 2017 updated by: C. R. Bard
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
248
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ohio
-
Cleveland, Ohio, United States, 44106
- University Hospitals Case Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 89 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: AccuCath IV Catheter Device
AccuCath IV Catheter System will be used for IV therapy during inpatient stay.
Intervention includes vascular access, fluid infusion, and blood sample removal
|
Vascular access and indwelling catheter placement via study device for infusion of fluids and removal of blood samples.
Other Names:
|
Active Comparator: Conventional IV Catheter Device
Conventional IV catheter (current catheter) will be used for IV therapy during inpatient stay.
Intervention includes vascular access, fluid infusion, and blood sample removal
|
Vascular access and indwelling catheter placement via control device for infusion of fluids and removal of blood samples.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
At catheter placement, an expected average of 10 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Completion of IV Therapy
Time Frame: Study exit/At catheter removal (~ up to 7 days)
|
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).
|
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)
|
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).
|
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)
|
Will measure total catheter dwell time to the nearest hour (total time in hours for functioning catheter) ~ up to 7 days.
|
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.
|
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.
|
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)
|
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.
|
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).
|
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.
|
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 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.
|
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)
|
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.
|
At IV removal (usually after 1-7 days of IV dwell time)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: James Rowbottom, MD, University Hospitals Cleveland Medical Center
- Principal Investigator: Bette Idemoto, PhD, RN, University Hospitals Cleveland Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
April 1, 2013
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
April 8, 2013
First Submitted That Met QC Criteria
September 11, 2013
First Posted (Estimate)
September 17, 2013
Study Record Updates
Last Update Posted (Actual)
March 9, 2017
Last Update Submitted That Met QC Criteria
January 18, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
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
Other Study ID Numbers
- DDVP-001/VPW-STP-00004
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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