Peripheral Intravenous Vein Catheter PhlebitisNCT04949854
Evaluating the Role of the Guidewire in Peripheral Intravenous Access
A study testing B.Braun 6.35 cm 20 Gauge ultralong intravenous catheter and B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter in people with Peripheral Intravenous Vein Catheter Phlebitis and Intravenous Infection, run by Corewell Health East at 1 site in United States.
Trial summary
This study is to demonstrate that the control ultralong intravenous catheter without the guide wire is equivalent to the experimental catheter with the guide wire. The hypothesis of this study is that the 6.35 cm 20G ultralong Ultrasound Guided Peripheral Intravenous (USPIV) will have no difference in survival… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Intravenous Vein Catheter Phlebitis, Intravenous Infection
- What is being tested?
- B.Braun 6.35 cm 20 Gauge ultralong intravenous catheter and B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2023to Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Eligible patients must be:
- ≥ than 18 years old
- Vascular Access Score 4 or 5.
Clinicians Eligibility Criteria:
- Clinician working in the emergency room (physician, advanced practice provider, nurse, technician) OR clinician working on the inpatient vascular access team (advanced practice provider, nurse)
- Greater than 6 months experience in ultrasound guided IV insertions
Patients are excluded:
- <18 years old
- Restricted mobility of elbow joint
- Cognitively impaired
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Role of the Guidewire in Peripheral Intravenous Access: A Randomized Controlled Trial of Ultrasound-Guided Catheter Survival
This study is to demonstrate that the control ultralong intravenous catheter without the guide wire is equivalent to the experimental catheter with the guide wire. The hypothesis of this study is that the 6.35 cm 20G ultralong Ultrasound Guided Peripheral Intravenous (USPIV) will have no difference in survival compared to the 5.71 cm ultralong with wire USPIV.
Read the detailed description
Peripheral intravenous catheter (PIVC) insertion is a standard hospital procedure that enables providers to rapidly administer fluids, medications, or blood products directly into a patients vein. This allows patients who have difficulty with tolerating oral intake or patients who are being prepared for surgery to still receive the proper treatments. Furthermore, because many medications are not designed to be administered orally, a PIVC is often used.
Despite being a common procedure, PIVC insertion routinely fails with failure rates of traditional blind intravenous (IV) catheter placement ranging from 19%-29.9%. Common causes of failure include infiltration, occlusion, dislodgement, phlebitis, and infection. In addition to increasing costs, multiple placements of an IV catheter during a hospital stay places a considerable time burden on hospital staff. One effort to alleviate this burden has been the introduction of ultrasound, which is shown to help mitigate failure rates of PIVC placement in patients with difficult vascular access. .
The catheter length in vein is the single most relevant variable in determining catheter survival in USPIV insertions. IV Catheter survival depends on the length of the catheter inside the veins. Vein depth and angle of insertion play a significant role in choosing the right catheter length to achieve the ideal quantity of catheter in vein. When a shallow angle is used, the catheter distance to the vein also increases and longer catheters are needed to achieve the optimal 2.75 cm in vein. Unfortunately, the longest most commonly stocked peripheral IV catheter at most institutions is 4.78 cm. This length is inadequate for insertions with a vein depth of greater than approximately 0.75 cm. As this is a commonly encountered vein depth, longer peripheral IV catheters are needed to ensure improved catheter survival.Few peripheral intravenous catheter options exist with the Ultra Long profile. The 6.35 cm B. Braun deep access device and the BD 5.71 cm Accucath device are two commercially available options for this category of ultra long peripheral IVs. Both catheters are available and being used in Beaumont Hospital.The 6.35 cm option is similar to other peripheral IV catheters and is inserted using the same technique applied for all ultrasound guided IV insertions. The 5.71 cm option is similar to other peripheral IVs with the additional feature of a built-in wire within the device to help guide the catheter in the vein once the needle has penetrated the vein. The cost of the 5.71 cm option is approximately ten times the cost of the 6.35 cm device.
Adult patients with a Vascular Access Score of 4 or 5 (where Score 1= Visible with distention and easily palpable; Score 2=Visible and easily palpable; Score 3= Not visible and easily palpable; Score 4=Visible and poorly palpable and Score 5=Not visible and poorly or non-palpable) will be approached for inclusion in the study.
- Being tested
- B.Braun 6.35 cm 20 Gauge ultralong intravenous catheter, B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter
- Keywords
- PIV, BBraun Ultra Long Catheter, BD Accucath, Phlebitis, IV Infection
- Medical subject headings
- Phlebitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
B.Braun 6.35 cm 20 Gauge ultralong intravenous catheterDevice
control Arm 1 (6.35 cm 20 Gauge ultralong intravenous catheter without guidewire
B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheterDevice
Experimental Arm B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter with guide wire
| Study group | Role | What they receive |
|---|---|---|
| Control Arm B.Braun 6.35 cm 20 Gauge catheter | Active comparator | Device 6.35 cm 20 Gauge B. Braun catheter without guidewire Receives: Device: B.Braun 6.35 cm 20 Gauge ultralong intravenous catheter |
| Experimental Arm B.D. Accucath 5.71 cm 20 Gauge catheter | Experimental | Device BD 5.71 cm Accucath IV catheter with guidewire Receives: Device: B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Catheter survival
Survival in hours or days of the catheter will be evaluated by functionality of catheter for intravenous therapy prior to patient discharge. The event of interest is failure of functionality identified during follow-up assessment during hospitalization.
Measured: During hospitalization, up to 60 days
Secondary outcomes (6)
First-stick success.
Number of patients with only one puncture of skin to achieve venous access
Measured: First day of hospitalization
Time to insertion
Time to insertion (measured in minutes) is defined as needlestick to dressing application.
Measured: First day of hospitalization
Provider proficiency
Change in mean number of attempts per patient for successful insertion, from baseline mean for first three patients attempted to last three patients attempted.
Measured: Study period, a maximum of 1 year
Total cost for all vascular access needs during hospitalization.
Cost per patient for vascular access during hospitalization, comprising (i) direct costs of IV insertion based on estimated labor and material cost per insertion attempt and estimated similar costs for rescue devices if needed and (ii) cost of treatment based on estimated cost per hour.
Measured: During hospitalization, up to 60 days
Catheter-associated thrombosis
The number of patients with all symptomatic catheter related upper extremity venous thrombosis inclusive of superficial thrombophlebitis (SVT), deep venous thrombosis(DVT), and pulmonary embolism will be confirmed by upper extremity doppler evaluation, computed tomography, and/or ventilation perfusion testing.
Measured: During hospitalization, up to 60 days
Catheter-associated bloodstream infection
The number of patients with catheter-associated bloodstream infection. Cases of infection will be diagnosed per laboratory confirmed bloodstream infection criteria published by the National Healthcare Safety Network (NHSN) and identified by the Department of Epidemiology at Beaumont Hospital.
Measured: During hospitalization, up to 60 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2021
- Study startDec 2023 (estimated)
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Why it stopped: Protocol was substantially revised
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Intravenous Vein Catheter PhlebitisStudies of the same condition, open and under way.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a prospective, parallel, non-blinded, two-arm randomized (like the flip of a coin) controlled trial of catheter failure evaluating the impact of a built-in guide wire. This study plans to enroll 360 participants (two equally sized groups of 180 participants in each arm).
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corewell Health East
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amit Bahl, MD., Principal investigator, Corewell Health East
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04949854
- Sponsor's protocol ID
- 2021-049
- Status last verified
- Sep 2023
- First submitted
- 1 Jun 2021
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Role of the Guidewire in Peripheral Intravenous Access: A Randomized Controlled Trial of Ultrasound-Guided Catheter Survival
- ClinicalTrials.gov ID
- NCT04949854
- Acronym / sponsor ID
- 2021-049
- Keywords
- PIV, BBraun Ultra Long Catheter, BD Accucath, Phlebitis, IV Infection
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Protocol was substantially revised
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Corewell Health EastUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 2 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to demonstrate that the control ultralong intravenous catheter without the guide wire is equivalent to the experimental catheter with the guide wire. The hypothesis of this study is that the 6.35 cm 20G ultralong Ultrasound Guided Peripheral Intravenous (USPIV) will have no difference in survival compared to the 5.71 cm ultralong with wire USPIV.
Detailed description
Peripheral intravenous catheter (PIVC) insertion is a standard hospital procedure that enables providers to rapidly administer fluids, medications, or blood products directly into a patients vein. This allows patients who have difficulty with tolerating oral intake or patients who are being prepared for surgery to still receive the proper treatments. Furthermore, because many medications are not designed to be administered orally, a PIVC is often used.
Despite being a common procedure, PIVC insertion routinely fails with failure rates of traditional blind intravenous (IV) catheter placement ranging from 19%-29.9%. Common causes of failure include infiltration, occlusion, dislodgement, phlebitis, and infection. In addition to increasing costs, multiple placements of an IV catheter during a hospital stay places a considerable time burden on hospital staff. One effort to alleviate this burden has been the introduction of ultrasound, which is shown to help mitigate failure rates of PIVC placement in patients with difficult vascular access. .
The catheter length in vein is the single most relevant variable in determining catheter survival in USPIV insertions. IV Catheter survival depends on the length of the catheter inside the veins. Vein depth and angle of insertion play a significant role in choosing the right catheter length to achieve the ideal quantity of catheter in vein. When a shallow angle is used, the catheter distance to the vein also increases and longer catheters are needed to achieve the optimal 2.75 cm in vein. Unfortunately, the longest most commonly stocked peripheral IV catheter at most institutions is 4.78 cm. This length is inadequate for insertions with a vein depth of greater than approximately 0.75 cm. As this is a commonly encountered vein depth, longer peripheral IV catheters are needed to ensure improved catheter survival.Few peripheral intravenous catheter options exist with the Ultra Long profile. The 6.35 cm B. Braun deep access device and the BD 5.71 cm Accucath device are two commercially available options for this category of ultra long peripheral IVs. Both catheters are available and being used in Beaumont Hospital.The 6.35 cm option is similar to other peripheral IV catheters and is inserted using the same technique applied for all ultrasound guided IV insertions. The 5.71 cm option is similar to other peripheral IVs with the additional feature of a built-in wire within the device to help guide the catheter in the vein once the needle has penetrated the vein. The cost of the 5.71 cm option is approximately ten times the cost of the 6.35 cm device.
Adult patients with a Vascular Access Score of 4 or 5 (where Score 1= Visible with distention and easily palpable; Score 2=Visible and easily palpable; Score 3= Not visible and easily palpable; Score 4=Visible and poorly palpable and Score 5=Not visible and poorly or non-palpable) will be approached for inclusion in the study.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a prospective, parallel, non-blinded, two-arm randomized (like the flip of a coin) controlled trial of catheter failure evaluating the impact of a built-in guide wire. This study plans to enroll 360 participants (two equally sized groups of 180 participants in each arm).
| Arm | Type | Receives |
|---|---|---|
| Control Arm B.Braun 6.35 cm 20 Gauge catheter | Active comparator | Device: B.Braun 6.35 cm 20 Gauge ultralong intravenous catheterDevice 6.35 cm 20 Gauge B. Braun catheter without guidewire |
| Experimental Arm B.D. Accucath 5.71 cm 20 Gauge catheter | Experimental | Device: B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheterDevice BD 5.71 cm Accucath IV catheter with guidewire |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| B.Braun 6.35 cm 20 Gauge ultralong intravenous cathetercontrol Arm 1 (6.35 cm 20 Gauge ultralong intravenous catheter without guidewire | Device | Control Arm B.Braun 6.35 cm 20 Gauge catheter |
| B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheterExperimental Arm B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter with guide wire | Device | Experimental Arm B.D. Accucath 5.71 cm 20 Gauge catheter |
Primary outcome
Catheter survival
Time frame: During hospitalization, up to 60 days
Survival in hours or days of the catheter will be evaluated by functionality of catheter for intravenous therapy prior to patient discharge. The event of interest is failure of functionality identified during follow-up assessment during hospitalization.
6 secondary outcomes
First-stick success.
Time frame: First day of hospitalization
Time to insertion
Time frame: First day of hospitalization
Provider proficiency
Time frame: Study period, a maximum of 1 year
Total cost for all vascular access needs during hospitalization.
Time frame: During hospitalization, up to 60 days
Catheter-associated thrombosis
Time frame: During hospitalization, up to 60 days
Catheter-associated bloodstream infection
Time frame: During hospitalization, up to 60 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Peripheral Intravenous Vein Catheter Phlebitis
Recruiting
Evaluating the Role of the Guidewire in Peripheral Intravenous Access: A Randomized Controlled Trial of Ultrasound-Guided Catheter Survival
Peripheral Intravenous Vein Catheter Phlebitis, Intravenous Infection
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.
Amit Bahl, MD. principal investigator
Corewell Health East
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing B.Braun 6.35 cm 20 Gauge ultralong intravenous catheter and B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter in people with Peripheral Intravenous Vein Catheter Phlebitis and Intravenous Infection, run by Corewell Health East 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?
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: withdrawn, as of the sponsor's last update on 18 Sep 2023. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Catheter survival (time frame: During hospitalization, up to 60 days). 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 18 Sep 2023.