An interventional study of B.Braun 6.35 cm 20 Gauge ultralong intravenous catheter and B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter in Peripheral Intravenous Vein Catheter Phlebitis and Intravenous Infection, sponsored by William Beaumont Hospitals. Withdrawn at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-09-18.
Sponsored by William Beaumont Hospitals · Not applicable, Interventional, and Other
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.
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.
45 studies on the registry are indexed under Phlebitis; 9 are open to participants now.
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Eligible patients must be:
Clinicians Eligibility Criteria:
Patients are excluded:
Device 6.35 cm 20 Gauge B. Braun catheter without guidewire
Device: B.Braun 6.35 cm 20 Gauge ultralong intravenous catheter
Device BD 5.71 cm Accucath IV catheter with guidewire
Device: B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter
control Arm 1 (6.35 cm 20 Gauge ultralong intravenous catheter without guidewire
Experimental Arm B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter with guide wire
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.
Time frame: During hospitalization, up to 60 days
First-stick success.
Number of patients with only one puncture of skin to achieve venous access
Time frame: First day of hospitalization
Time to insertion
Time to insertion (measured in minutes) is defined as needlestick to dressing application.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: During hospitalization, up to 60 days
Inflammatory complications by clinical assessment
Number of patients with inflammatory complications measured by a score of 2 or greater on a standardized visual phlebitis scale, with a range of 0 to 5 where 0 is no inflammation and 5 is advanced stage thrombophlebitis.
Time frame: During hospitalization, up to 60 days
Plan to share: No
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