Evaluating the Role of the Guidewire in Peripheral Intravenous Access

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Eligible patients must be: 1. ≥ than 18 years old. 2. Vascular Access Score 4 or 5. Clinicians Eligibility Criteria: 1. 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) 2. Greater than 6 months experience in ultrasound guided IV insertions. Patients are excluded: 1. <18 years old. 2. Restricted mobility of elbow joint. 3. Cognitively impaired

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04949854
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

William Beaumont Hospitals
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Amit Bahl, MD.
Principal Investigator Affiliation William Beaumont Hospitals
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Peripheral Intravenous Vein Catheter Phlebitis, Intravenous Infection
Additional Details

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.

Arms & Interventions

Arms

Active Comparator: Control Arm B.Braun 6.35 cm 20 Gauge catheter

Device 6.35 cm 20 Gauge B. Braun catheter without guidewire

Experimental: Experimental Arm B.D. Accucath 5.71 cm 20 Gauge catheter

Device BD 5.71 cm Accucath IV catheter with guidewire

Interventions

Device: - B.Braun 6.35 cm 20 Gauge ultralong intravenous catheter

control Arm 1 (6.35 cm 20 Gauge ultralong intravenous catheter without guidewire

Device: - B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter

Experimental Arm B.D Accucath 5.71 cm 20 Gauge ultralong intravenous catheter with guide wire

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Beaumont Hospitals, Royal Oak, Michigan

Status

Recruiting

Address

Beaumont Hospitals

Royal Oak, Michigan, 48073

Site Contact

Amit Bahl, MD

[email protected]

248-898-2001