Vascular Access ComplicationNCT02449798
Prospective Feasibility Trial of AccuCath 2.25" Blood Control (BC) Placed in Difficult Access Patients in the Emergency Department
A study testing AccuCath 2.25" BC Intravascular Catheter in people with Vascular Access Complication, run by C. R. Bard at 1 site in United States.
Trial summary
Study objective is to evaluate user preference, time for procedure, insertion success rates, complications, completion of therapy and dwell time of the AccuCath 2.25" BC device placed in difficult IV access patients in the emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vascular Access Complication
- What is being tested?
- AccuCath 2.25" BC Intravascular Catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2015to Jul 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female, age > 18 years old;
- Capable and willing to give informed consent;
- English speaking;
- Acceptable candidate for an elective, non-emergent peripheral IV as determined by ordering physician;
- Admitted to inpatient area for minimum of 24 hours, preferably for average hospital length of stay;
- Difficult venous access patient as defined by either 2 failed initial attempts without ultrasound guidance or a history of difficult access plus the inability to directly visualize or palpate a target vein.
Who cannot join
- Male or female, < 18 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;
- Subjects with lymphedema or status-post mastectomy on affected side;
- 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
North Shore - Long Island Jewish Health System
Manhasset, New York, 11030
About this study
Official title: A Prospective Feasibility Trial of AccuCath 2.25" BC Intravascular Catheter System With Retractable Coiled Tip Guidewire Placed in Difficult Access Patients in the Emergency Department
Study objective is to evaluate user preference, time for procedure, insertion success rates, complications, completion of therapy and dwell time of the AccuCath 2.25" BC device placed in difficult IV access patients in the emergency department.
Read the detailed description
A one arm, prospective feasibility study using the AccuCath 2.25" BC Intravascular Catheter System placed in the upper arm with ultrasound guidance, and the lower arm with and without ultrasound guidance based on clinical assessment. Subjects will be subjected to a maximum of 4 attempts. If unsuccessful by the 4th attempt, alternatives will be considered as per current standard of care.
Currently multiple IV attempts are made in difficult IV access patients without success. Patients are often escalated to more invasive lines due to the need for longer catheters without clinical indication. The study will evaluate the feasibility of AccuCath 2.25" BC as a low risk, lower cost alternative for this patient population in lieu of using a midline, peripherally inserted central line or central venous catheter when not clinically required for purposes of therapy.
- Conditions
- Vascular Access Complication
- Being tested
- AccuCath 2.25" BC Intravascular Catheter
- Keywords
- Difficult IV access, AccuCath, IV outcomes, patient satisfaction
- Medical subject headings
- Patient Satisfaction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuCath 2.25" BC Intravascular CatheterDevice
Also called AccuCath, AccuCath peripheral IV, AccuCath IV device, AccuCath catheter system
Long peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance.
| Study group | Role | What they receive |
|---|---|---|
| AccuCath 2.25" BC Intravascular Catheter | Experimental | Use of AccuCath 2.25" BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins. Receives: Device: AccuCath 2.25" BC Intravascular Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
First Attempt Success Rate
Measured: At initial IV insertion attempt, generally from 3-15 minutes
Number of Catheter Attempts Required to Complete Successful PIV Placement
Measured: At IV insertion attempt, generally from 3-15 minutes
Secondary outcomes (6)
Time to Catheter Placement
Time will be measured from initial vessel insertion through successful cannulation
Measured: At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes
Complications
Count of IV complications that require IV removal before completion of therapy. Includes infiltration, extravasation, phlebitis, occlusion, dislodgement, infection, leaking at site, pain at site
Measured: During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days
Dwell Time
IV dwell time in hours until IV is no longer needed or complicates.
Measured: Duration of IV dwell from initial insertion success through IV removal, usually ranges from 0-336 hours (0-14 days) but could be up to 696 hours (29 days)
Completion of Therapy
Count of whether the catheter lasted for the duration of intended therapy without complication requiring early removal.
Measured: During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days
Patient Satisfaction
A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV insertion experience. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive.
Measured: At end of IV insertion, first 3-15 minutes of procedure
Patient Satisfaction
A 5-point Likert scale (1-5) was used for measurement of satisfaction with overall IV performance at IV removal. A score of 1 indicated the lowest satisfaction, while a score of 5 indicated the highest satisfaction. A score of 3-5 was considered positive.
Measured: at IV removal, which can be up to a maximum of 29 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startMar 2015
- Primary completionJun 2015
- Study completionJul 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 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- C. R. Bard
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christopher Raio, MD, Principal investigator, Northwell Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02449798
- Sponsor's protocol ID
- VPW-STP-00007
- Status last verified
- Mar 2017
- First submitted
- 16 May 2015
- Last updated
- 14 Apr 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 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Feasibility Trial of AccuCath 2.25" BC Intravascular Catheter System With Retractable Coiled Tip Guidewire Placed in Difficult Access Patients in the Emergency Department
- ClinicalTrials.gov ID
- NCT02449798
- Acronym / sponsor ID
- VPW-STP-00007
- Conditions
- Vascular Access Complication
- Keywords
- Difficult IV access, AccuCath, IV outcomes, patient satisfaction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- C. R. BardIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 20 May 2015 (estimated)
- Results
- Posted 14 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study objective is to evaluate user preference, time for procedure, insertion success rates, complications, completion of therapy and dwell time of the AccuCath 2.25" BC device placed in difficult IV access patients in the emergency department.
Detailed description
A one arm, prospective feasibility study using the AccuCath 2.25" BC Intravascular Catheter System placed in the upper arm with ultrasound guidance, and the lower arm with and without ultrasound guidance based on clinical assessment. Subjects will be subjected to a maximum of 4 attempts. If unsuccessful by the 4th attempt, alternatives will be considered as per current standard of care.
Currently multiple IV attempts are made in difficult IV access patients without success. Patients are often escalated to more invasive lines due to the need for longer catheters without clinical indication. The study will evaluate the feasibility of AccuCath 2.25" BC as a low risk, lower cost alternative for this patient population in lieu of using a midline, peripherally inserted central line or central venous catheter when not clinically required for purposes of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AccuCath 2.25" BC Intravascular Catheter | Experimental | Device: AccuCath 2.25" BC Intravascular CatheterUse of AccuCath 2.25" BC peripheral IV device for difficult IV access in emergency room patients who have had 2 previous attempts, identified as difficult IV access from patient history or non-palpable, non-visible veins. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female, age > 18 years old;
- Capable and willing to give informed consent;
- English speaking;
- Acceptable candidate for an elective, non-emergent peripheral IV as determined by ordering physician;
- Admitted to inpatient area for minimum of 24 hours, preferably for average hospital length of stay;
Key exclusion criteria (5 listed)
- Male or female, < 18 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;
- Subjects with lymphedema or status-post mastectomy on affected side;
- 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 2.25" BC Intravascular CatheterAlso: AccuCath, AccuCath peripheral IV, AccuCath IV device, AccuCath catheter systemLong peripheral IV catheter designed for difficult IV access patients requiring deeper vessel access, often used with ultrasound guidance. | Device | AccuCath 2.25" BC Intravascular Catheter |
Primary outcome
First Attempt Success Rate
Time frame: At initial IV insertion attempt, generally from 3-15 minutes
Number of Catheter Attempts Required to Complete Successful PIV Placement
Time frame: At IV insertion attempt, generally from 3-15 minutes
6 secondary outcomes
Time to Catheter Placement
Time frame: At initial IV insertion attempt through successful cannulation, generally from 3-15 minutes
Complications
Time frame: During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days
Dwell Time
Time frame: Duration of IV dwell from initial insertion success through IV removal, usually ranges from 0-336 hours (0-14 days) but could be up to 696 hours (29 days)
Completion of Therapy
Time frame: During IV dwell from initial insertion success through IV removal, usually ranges from 7-14 days but could be up to 29 days
Patient Satisfaction
Time frame: At end of IV insertion, first 3-15 minutes of procedure
Patient Satisfaction
Time frame: at IV removal, which can be up to a maximum of 29 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Vascular Access Complication
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.
Christopher Raio, MD principal investigator
Northwell Health
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 2.25" BC Intravascular Catheter 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 6 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 14 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 14 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?
First Attempt Success Rate (time frame: At initial IV insertion attempt, generally from 3-15 minutes). The study lists 2 primary outcomes in all. 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 14 Apr 2017.