130 Clinical Trials for Various Conditions
The Velocity Percutaneous Arterio-Venous System is a minimally invasive method of creating hemodialysis vascular access. The study aims to understand clinical efficacy and initial clinical safety data of the device.
This post-market study is being conducted to generate safety and performance data on the BD Prevue(TM) II Peripheral Vascular Access System with Cue(TM) Needle Tracking Technology. The data will be utilized to support regional registrations (for example, EU MDR), and document any unforeseen residual risks.
This pragmatic, randomized study seeks to evaluate the applications of a novel vibrating device for reducing pediatric anxiety and distress during vascular access procedures.
The focus of this study is on vascular access for hemodialysis. This is a randomized clinical trial testing 3 educational approaches to help patients with advanced chronic kidney disease prepare for placement of hemodialysis vascular access. Study participants will each be assigned to one of the 3 approaches: 1) "Education", in which participants will be given a video and brochure that provide information about the types of vascular access and what can be expected before and after the vascular access is placed, 2) "Education-Plus", in which participants will be given the video and brochure and will also have sessions by telehealth with a motivational interviewing coach to provide additional support around vascular access placement, and 3) "Usual Care", in which participants will have the usual education provided by their kidney doctor and clinic staff just as if they were not in the study. Participants in all 3 groups will be asked to complete questionnaires by telephone and may be invited to be interviewed about their experience with the study intervention at the end of the study. Study participation will last for about 12 months, with most of the study activities taking place during the first 3 months.
The perioperative setting is a common site of pediatric anxiety and distress. Perioperative anxiety in pediatric patients can result in uncooperative behavior, poor postoperative outcomes, and trauma. Given the fast-paced nature of the perioperative environment, many anxiety measures are too time consuming for clinical implementation prior to surgery. Pediatric anesthesiologists need reliable and efficient assessment tools to quickly measure childhood distress to target prophylactic and therapeutic interventions.
Researchers are evaluating the clinical efficiency of utilization of a dual-plane simultaneous view ultrasound probe (Butterfly iQ+; Butterfly Network, Inc.) during arterial catheter placement in the operating room
The proposed clinical study is a prospective, non-randomized, multi-center, single-arm, observational, post-market surveillance (PS) study of the Ellipsys Vascular Access System in subjects eligible for arteriovenous (AV) fistula.
This first-in-human pilot study seeks to evaluate the feasibility and safety of using a percutaneous ultrasound device with needle guide for vascular access. Eligible participants will undergo the procedure of transcatheter arterial chemoembolization for primary or metastatic liver cancer, as part of participants' clinical care. The percutaneous ultrasound device with needle guide will be deployed in eligible participants at the beginning of the procedure for guiding a needle inside the femoral artery. Once the needle is inside the artery, then a guide wire is advanced inside the needle and vascular access is successfully obtained. The study will identify whether this ultrasound-based device with needle guide is helpful for guiding a needle inside the femoral artery.
Preprocedural, preoperative, and prevascular access anxiety in pediatric patients has been previously shown to increase the likelihood of family stressors, postoperative pain, agitation, sleep disturbances, and negative behavioral changes. The purpose of this study is to determine if a non-invasive distracting devices (Virtual Reality headset) is more effective than the standard of care (i.e., no technology based distraction) for preventing anxiety before vascular access among hospitalized children undergoing vascular access prior to anesthesia, procedures, surgery, blood draws, port access, or peripheral IV placement. The anticipated primary outcome will be reduction of child's anxiety during and after vascular access.
The goal of this study is to find the best techniques to take non-invasive images of the arteriovenous fistula (AVF) in hemodialysis patients.
A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.
Obtaining peripheral vascular access in medical patients is a necessary procedure for many healthcare providers. Peripheral vascular access is traditionally performed using palpation or visual inspection to identify appropriate points of entry in the vasculature after which a needle and catheter are threaded through the skin and surround fascia into the vessel of interest. This procedure, one of the most common procedures in the medical field including both artery and vein access, is not 100% successfully attempted. Operator skill heavily influences peripheral vascular cannulation. (Frisch et al. 2013) However, certain patient populations have difficult peripheral vessels to identify by palpation or visual inspection and past operators would be forced to perform the procedure blind based on anatomical landmarks. Recently, to aid vascular identification and increase cannulation success, a number of alternative techniques for peripheral vascular access have been described including ultrasound-guided. Ultrasound-guided vascular access has been utilized in vascular access with improved success rate. However, even with ultrasound guidance the first attempt success rate of cannulation was only approximately 65%. A proposed failure of ultrasound guided peripheral vascular access is most likely due to failure to advance the catheter into the vessel even the vessel was successfully punctured. The investigators propose a specific technique and the positive "Target Sign" as a means to obtain almost 100% successful peripheral vascular access. The investigators plan to enroll 100 surgical patients in the above study and study procedures will not differ from what a patient in the operating room under the care of anesthesia faculty would receive. The above study is simply a way to identify the steps regarding a specific technique.
The study will test a hypothesis that the AccuCath™ System will have a higher rate of successful first attempt peripheral intravenous (PIV) placement, higher completion of therapy, fewer complications, longer dwell times, and higher user satisfaction compared to Conventional IV Catheters.
A prospective study to determine the safety of intraosseous (IO) access for a period up to 48 hours in healthy adult volunteers and volunteers with a history of mild to moderate renal disease and/or controlled diabetes.
The purpose of this study is to determine if there is one method of identifying the proximal humerus intraosseous vascular access site that is easier for clinicians to use, out of the 4 methods being evaluated.
The objective of this study is to show VeinViewer® Vision is an effective vein visualization device for peripheral vascular access, pre-, during, and post access.
Intraosseous vascular access can be used to effectively and safely deliver contrast dye for CT examination.
The purpose of this study is to evaluate the use of powered intraosseous vascular access (EZ-IO by Vidacare) in the emergency department for patients requiring urgent vascular access. Data collected will be compared to historical data on central venous catheter use in the emergency department. The primary hypothesis is that powered intraosseous vascular access will decrease the amount of time needed to obtain vascular access.
The objective of this study will be to compare humeral and tibial IO needle insertions to peripheral IV access during cardiac arrest. Hypothesis There is a difference in first attempt success of tibial IOs compared to humeral IOs or peripheral IV among cardiac arrest patients. This was a randomized trial of adult patients experiencing a medical OOHCA where resuscitation efforts were initiated. Patients were randomized to 1 of 3 routes of vascular access. Prior to every shift, paramedics were distributed a randomly selected note card indicating the prescribed route for vascular access: tibial IO, humeral IO, or peripheral IV. The selected method applied to the first attempt at vascular access only. Paramedics received intensive training and exposure to all three methods prior to study initiation. The primary outcome was first attempt success defined as secure needle position in the marrow cavity or a peripheral vein with normal fluid flow. Needle dislodgement during resuscitation was counted as a failure to maintain vascular access. In order to detect a statistical difference in the frequency of first attempt success a minimum of 50 patients for each arm of the study were needed.
The purpose of this study is to determine whether the long term use of the experimental Vascular Wrap(TM) Paclitaxel-Eluting Mesh is safe in the treatment of subjects needing hemodialysis access (via an expanded polytetrafluoroethylene (ePTFE) graft).
Patients in renal failure on hemodialysis depend on adequate and sustained vascular access. This can be achieved by surgical placement of a synthetic polytetrafluoroethylene (PTFE) graft. These patients frequently experience graft complications arising from the development of smooth muscle cell (SMC) neointimal hyperplasia in the proximity of the graft-vein anastomosis. Such complications eventually lead to stenosis, access thrombosis and graft failure. Trinam® is being developed to prolong graft survival. It is a combination product consisting of a replication deficient Adenovirus containing the human Vascular Endothelial Growth Factor D (Ad-VEGF-D) gene and a biodegradable local delivery device (collar) made of collagen. At the end of the surgical procedure to insert the PTFE graft the collagen collar is applied around the anastomosis and sealed with a collagen surgical sealant. This procedure creates a reservoir between the site of anastomosis and the collagen collar. The adenoviral vector is then injected into this reservoir, localizing the expression of the transgene to the site of the anastomosis. Expression of VEGF-D has been shown to have a vascular protective role and inhibit SMC neointimal proliferation, therefore expression of VEGF-D should prolong graft survival.
This project involves a pre- and post- airway management and vascular access simulation survey. The purpose of the study is to assess the perceived effectiveness of the simulation course on the performance of medical students enrolling in the Anesthesiology rotation during their third and fourth year of medical education.
Compare the HeRO Vascular Access Device to a conventional ePTFE graft.
The purpose of this study is to compare the safety and effectiveness of the HeRO Vascular Access Device in access challenged (e.g., catheter-dependent) hemodialysis patients. It is hypothesized the bacteremia rate associated with the HeRO device will be lower than a historical literature control of tunneled dialysis catheters.
Multicenter randomized study to compare powered intraosseous access to standard central line access for the administration of fluids and drugs for patients in the Emergency Dept.
This is a multi-center clinical study in subjects requiring arteriovenous grafts in the upper extremity for hemodialysis access. All subjects will provide informed consent before undergoing any study procedures. The study will consist of multiple subject visits and telephone contacts during the 52 week study period. During the study period subjects must also maintain an appropriate hemodialysis schedule. IDE Number: G060250
Inadvertent puncture of an unintended object in a vascular access procedure is common and can lead to serious consequences. Inadvertent common carotid artery (CCA) puncture while targeting the internal jugular vein (IJV), for example, is reported to have an incidence of 2% - 8% and usually results in localized hematoma formation. The hematoma may enlarge rapidly if the patient is coagulopathic, or if a large puncture wound is produced by the introduction of the sheath itself into the CCA. Airway obstruction, pseudoaneurysm, arterio-venous fistula formation and retrograde aortic dissection have all been reported as a consequence of CCA puncture. In the presence of occlusive (atheromatous) carotid disease, inadvertent puncture may carry the risk of precipitating a cerebrovascular accident. In this study, we aim to collect color Doppler and B-mode ultrasound videos from the most common ultrasound-guided vascular access sites - internal jugular vein, subclavian vein, femoral vein, basilic vein, and brachial vein. The videos will also include structures in close proximity to the intended veins. Using such database, we will run various vessel tracking and identification algorithms to evaluate their performance. Our ultimate goal is to develop an algorithm that will aid the ultrasound operator in identifying structures and differentiating between arteries and veins.
This study is designed to confirm the safety of the proposed dose and schedule of ABI-007 for hemodialysis patients with vascular access device failure, and to obtain preliminary data on the effectiveness of such treatment.
The purpose of this study is to see how fast and accurate two different techniques used by physicians to insert catheters in children are. Catheters are tiny tubes which carry fluids, blood and sometimes liquid food into a person's vein. The technique currently used relies on the physical landmarks and using fingers to feel the anatomy in which to place the catheter in the vein or artery. The investigators are changing to a technique where they will use ultrasound at the patient's bedside to help physicians with placing the catheter into the blood vessel. They are comparing the use of these two methods to determine which is faster and requires fewer needle sticks.
Vascular access is considered the Achilles heel of the dialysis patient. It constitutes the largest single cause of morbidity in the chronic hemodialysis population, accounting for over 25% of hospitalizations at an estimated cost in the US of at least one billion dollars annually. Currently, complication free survival of vascular access ranges between 30-50% a year and multiple investigative efforts in this area have been initiated and are directed at prolonging the functional life of vascular accesses. It is not well established whether intervention prior to overt malfunction or thrombosis of the vascular access could reduce these complications and thereby improve the functional longevity of the access. Moreover, once accesses at potential risk are identified, it is not well established which method of intervention, Surgery vs. Angioplasty vs. Expectant Management, is superior in terms of clinical and financial outcome. The proposed study aims to determine whether early intervention of a vascular access determined to be at risk of malfunction and thrombosis improves the long term outcome and, specifically, which means of intervention is preferred.