Treatment Trials

39 Clinical Trials for Various Conditions

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COMPLETED
A Comparison of the Success Rate Of Cannulation Between The Accuvein Apparatus And Standard Technique
Description

1. This study will compare the first attempt success rate of cannulation in research participants randomized to using a new FDA approved AccuVein AV300 device for intravenous access with research participants randomized to standard cannulation methods. 2. This study will assess if insertion of intravenous cannula is faster when intravenous access is assisted by the AccuVein AV300 device as compared to the standard technique. 3. This study will assess if the number of skin punctures is fewer when intravenous access is assisted by the AccuVein AV300 device as compared to the standard technique.

Conditions
TERMINATED
Femoral Arterial Cannulation
Description

Many children undergoing surgery for congenital heart disease have had prior operations. Re-operative sternotomy carries with it the risk of cardiac injury and the need for emergent peripheral cannulation. Our first aim is to demonstrate that peripheral arterial cannulation may be lifesaving in cases of complicated sternal re-entry in children and that angio-catheters can be utilized when vessels are too small for standard cannulas. Our secondary aim is to present a case report of successful femoral cannulation in a 5 kg child.

COMPLETED
Needle-Knife Fistulotomy Vs. Standard Cannulation Trial
Description

Needle-knife fistulotomy (NKF) is traditionally used to achieve biliary access when standard cannulation (SC) techniques are unsuccessful. Based on technical factors and the design of prior studies, the literature suggests NKF should be reserved for expert advanced endoscopists. The aim of this study was to evaluate the efficacy and safety of NKF compared to SC for primary biliary access performed by advanced endoscopists with a range of experience including advanced endoscopy trainees.

RECRUITING
Study Examining the Effect of a Novel Cannulation Knife on User Satisfaction and Common Central Venous Catheter Insertion Complications
Description

The purpose of this study is to assess user satisfaction and the frequency of common central venous catheter insertion complications when using a novel cannulation knife.

COMPLETED
Impact of Cannulation Strategy on Neurologic Injury in Infants With Respiratory Failure
Description

There has been increasing use of venoarterial (VA) extracorporeal membrane oxygenation (ECMO) for infants with respiratory failure, up to 92% of neonatal respiratory support in 2021. This study seeks to leverage the increased use of VA ECMO in this cohort to enrich an evaluation of the differences in rate of intracranial hemorrhage and ischemic stroke between venovenous (VV) and VA ECMO among infants with respiratory failure where clinicians may choose either strategy. This project is a retrospective review of data in the ELSO registry.

COMPLETED
Angled-tip vs. Straight-tip Guidewire in Biliary Cannulation
Description

The investigators aim is to compare outcomes between an angled-tip guidewire and a straight-tip guidewire in cannulation of the common bile duct during ERCP. This is a randomized, controlled, single-blinded study. The primary outcome is success of cannulation and secondary outcomes are incidence of post-ERCP pancreatitis, procedure duration, and rate of complication between the angled wire and straight wire.

RECRUITING
Access Cannulation Trial II
Description

This is a pivotal, interventional, prospective, single-arm, open-label, multi-site clinical investigation intended to support FDA clearance of the study device based on the safety and efficacy of the device in cannulating arteriovenous fistulas (AVFs) for hemodialysis procedures.

COMPLETED
Study of Forceps Cannulation During ERCP
Description

A difficult cannulation has been identified as one of the high risk factors for developing post-ERCP pancreatitis (PEP). The accessibility and morphology of the papilla influence the level of cannulation difficulty. The use of a forceps to assist in the cannulation is a demonstrated effective technique for cannulating papillae that are difficult to access. Thus, the objective of our study is to determine whether a forceps assisted cannulation leads to less difficult cannulation during ERCP. Because difficult cannulation is associated with increased risk of PEP, our study investigates whether the forceps assisted cannulation also reduces the incidence of PEP as a secondary outcome. Eligible patients who have consented will either be randomized to cannulation with forceps or cannulation with no forceps.

ENROLLING_BY_INVITATION
Immune Profiles in Multiple Sclerosis (MS) Patients and Healthy Volunteers Through Thoracic Duct Cannulation
Description

In this study, lymph fluid will be collected by cannulation of the thoracic duct, a minimally invasive procedure performed by interventional radiologists. Single time point and serial collection through an indwelling cannula will allow for comparisons between immune cells in the periphery and deep lymphatic system in MS and healthy controls and in MS, changes in responses to a FDA approved therapy ofatumumab.

WITHDRAWN
Pilot Trial: Comparing Buzzy to Intradermal Lidocaine for Peripheral IV Cannulation in Adults
Description

IV placement is necessary for surgical procedures. Unfortunately, some patients say that placing an IV is painful. The investigators are conducting this study to evaluate two techniques that could make the placement of the IV more comfortable.

RECRUITING
Novel Device for Ultrasound-guided Pediatric Vessel Cannulations
Description

Clinical Trial to investigate whether the use of a novel device to be used in conjunction with ultrasound in pediatric vessel cannulations is superior to ultrasound-only pediatric vessel cannulations in terms of number of cannulation attempts.

COMPLETED
Image Guidance for Improved Vessel Cannulation in Pediatric Patients
Description

Feasibility Study This will be performed by an expert operator in Interventional Radiology who routinely performs CVC catheter placement, using appropriate pediatric human anatomy and vessel size, as well as real patient care scenarios.

WITHDRAWN
Washington Study of AxoTrack-Guided Central Venous Cannulation
Description

Undifferentiated hypotension is a medical emergency where a patient's blood pressure drops to critical levels due to several possible reasons. The medical staff treating the patient will need to find out the reason for your drop in blood pressure as soon as possible. When treating low blood pressure, the medical staff typically performs a procedure called central venous cannulation (CVC). CVC involves accessing a large vein (usually the subclavian under the collarbone) by inserting a needle into the vein. By doing this, the medical staff can measure the pressures in the patient's veins or give medicine to the patient while they are in the hospital. The purpose of this study is to compare the time needed to complete CVC using the AxoTrack device to CVC guided by landmarks on a patient's body. The investigators expect that there will be a maximum of 30 patients enrolled in this study.

Conditions
COMPLETED
Coronal Mode Ultrasound Guided Hemodialysis Cannulation: Comparison With Standard Cannulation Technique
Description

Infiltrations from cannulation difficulties result in significant morbidity including loss of vascular access (VA) loss in hemodialysis (HD). Cannulation is reliant on personnel skill and VA characteristics. Surface marking of VA lacks real-time information and traditional ultrasound (US) devices are large, expensive and require skilled operator expertise. Sonic Window© (Analogic Ultrasound, Peabody, MA) is a coronal mode ultrasound device (CMUD) approved for VA cannulation. Study is a single center randomized, prospective pilot study comparing handheld US-guided cannulation of new arteriovenous fistula (AVF) to standard cannulation practices.

COMPLETED
Optimal Timing of Double-Wire Technique For Biliary Cannulation at ERCP
Description

The purpose of this study is to give doctors who perform Endoscopic Retrograde Cholangiopancreatography (ERCP) procedures a better idea as to the best techniques to use in order to examine the bile duct as quickly and safely as possible.

COMPLETED
Randomized Trial of Wire and Sphincterotome Systems for Biliary Cannulation
Description

1. Cannulation of (placement of a small catheter into) the bile duct is critical to remove bile duct stones, divert bile leaks, and decompress biliary obstruction due to cancer. 2. Given the small size of the bile duct orifice and its close proximity to the pancreatic duct, selective biliary cannulation is the most difficult part of the endoscopic retrograde cholangiography (ERCP). 3. New small diameter sphincteromes and "short wire" systems (which allow physicians to control guidewires) offer potential, though untested advantages. 4. At most hosptial both the long and short wire systems as well as small versus standard are routinely used for clinical care. 5. Our hypothesis is that small diameter, physician controlled wires favor biliary cannulation 6. Our objective will be to assess whether small diameter sphincterotomes and "short wire" physician controlled guidewire cannulation favors successful bile duct cannulation and minimize complications.

COMPLETED
Optimal Neck Angle for Internal Jugular Cannulation
Description

Measurements will be made between the internal jugular vein and the carotid artery using an ultrasound machine as the subjects is asked to move and position his or her neck in various positions. It is hypothesized that by movements of the neck the investigators can maximize the distance between the internal jugular vein and the carotid artery to decrease inadvertent cannulation of the carotid artery to improve patient safety

Conditions
COMPLETED
Saphenous Vein Cannulation in Infants and Small Children
Description

The purpose of this study is to compare the two different saphenous vein cannulation techniques; real-time ultrasound image-guided technique (Ultrasound group) vs. traditional landmark technique (Landmark group).

COMPLETED
Rapydan Topical Anaesthesia for Arterial Cannulation
Description

Arterial catheterization is painful and is associated with patient stress and anxiety. Analgesia is usually provided by subcutaneous injection of local anesthetic. An alternative is topical anaesthesia, such as Rapydan which is a novel topical anesthetic patch containing 70 mg each of lidocaine and tetracaine. We therefore tested the hypothesis that Rapydan patch analgesia is non-inferior to subcutaneous local anesthetic.

COMPLETED
Vibrating, Cold Device for Pediatric Intravenous (IV) Cannulation Pain Relief
Description

The purpose of this study is to test the effectiveness of Buzzy®, a battery-powered reusable device that provides cold and vibration, in reducing the pain associated with intravenous (IV) cannulation. The investigators will investigate if Buzzy® is as effective as topical lidocaine cream in reducing the pain associated with IV cannulation.

Conditions
COMPLETED
Ultrasound-image Guided Versus Doppler Guided Versus Palpation Technique for Arterial Cannulation in Adults
Description

Radial arterial cannulation is a common invasive procedure for real-time measurement of arterial blood pressure. Placement of the arterial catheter using conventional palpation is often relatively easy and quick, but this is not always true. A relatively new method for direct visualization of the artery is the use of two-dimensional ultrasound. This technique allows cannulation of the artery to take place under real-time visualization and may increase the success rate of first time pass of the needle. Another technique utilizing Doppler has also proven to be effective in cannulating the radial artery. This technique utilizes changes in acoustic pitch as the probe passes directly over the artery. The primary objective of this study is to compare the first attempt success rate for radial artery cannulation among the palpation, Doppler and U/S guided technique when applied by trainees. Secondary outcomes include: success rate within 5 minutes, successful, number of attempts required, and correlation between success rate and operator experience for successful cannulation of the radial artery.

Conditions
COMPLETED
Pediatric Radial Arterial Cannulation
Description

This prospective randomized study was designed to compare ultrasound guided technique with Doppler assisted technique for radial arterial cannulation in infant and small children.

Conditions
COMPLETED
Comparison of Double Wire Technique With Pancreatic Duct Stent Placement for Difficult Bile Duct Cannulation
Description

This research project will compare the use of the double wire technique with the placement of a pancreatic duct (PD) stent to achieve deep biliary cannulation without the use of a precut papillotomy. Currently, the data supporting either of these approaches is limited to the referenced case series. More data on the success and complication rates of these techniques are needed. The investigators believe either of these approaches would be preferred by less experienced endoscopists to precut papillotomy. Consequently, it is important to differentiate these techniques and identify which patients may benefit from one or both.

COMPLETED
Ultrasound Guidance for Intravenous Cannulation in Emergency Department Patients.
Description

A randomized trial of the use of ultrasound by emergency physicians in the placement of intravenous catheters in emergency patients who are found to have difficult intravenous access (defined as two failed attempts by nursing staff).

TERMINATED
Veinplicity for Improved Venous Access: The VIVA Trial
Description

This study will assess the safety and effectiveness of the Veinplicity device to improve the visualization and palpability of difficult-to-access veins for intravenous cannulation.

TERMINATED
Target Sign vs Palpation for Radial Arterial Line Placement
Description

Invasive blood pressure monitoring is achieved by cannulating an artery and transducing the pressure. During arterial cannulation the artery can be located by palpation, but use of ultrasound has increased the success rate of cannulation. A new ultrasound technique for vascular cannulation (dynamic needle tip positioning) has been described. Investigators aim to compare this technique to the palpation technique for arterial cannulation. Investigators hypothesize that the use of this novel ultrasound technique will result in a higher first attempt success rate and overall success compared to palpation. Investigators plan to enroll 310 patients in this study. The participants in the study will have been deemed by the attending anesthesiologist to require a radial arterial line for the operation and thus the research protocol will not involve a deviation from the standard of care.

COMPLETED
Ultrasound Versus Fluoroscopically-guided Arterial Access in Non-cardiac Vascular Patients
Description

In the investigators vascular practice, either fluoroscopic- or ultrasound-guided technique is routinely used to obtain femoral arterial access. Ultrasound-guidance is frequently used in patients with weak or absent pulses, known abnormal vascular anatomy, need for bypass graft puncture, and to ensure accurate arterial puncture in patients expected to receive large doses of blood-thinning medications during or after the procedure. For those practitioners experienced with ultrasound-guided access techniques, it is considered highly accurate and easy to use; thus, some physicians routinely use this tool. A well-designed study is needed to truly assess the accuracy of the ultrasound technique and to determine whether it may reduce complications of arterial access in vascular patients. By demonstrating the safest, most accurate and efficient technique for obtaining arterial access during catheter-based procedures, the investigators could significantly reduce morbidity and mortality associated with complications of arterial puncture. Length of hospital stay, management costs and patient discomfort could be reduced by minimizing complication rates.

COMPLETED
Use of Vein Viewer for Insertion of Peripheral Venous Cannula in Pediatric Patients With Difficult Intravenous Access
Description

The primary purpose of this prospective, randomized trial is successful intravenous (IV) cannulation on first attempt with the use of either the Vein Viewer (VV) or standard cannulation method. The secondary purpose is to find out if there is a difference in the total time to successful cannulation.

Conditions
NOT_YET_RECRUITING
Effect of a Sacral Lift on Femoral Vein Size and Exposure
Description

The goal of this clinical trial is to learn if a sacral lift can improve femoral vein size and exposure, which may be clinically helpful during femoral vein cannulation among emergency department patients. The main questions it aims to answer are: Does a sacral lift increase femoral vein size compared to no sacral lift in both straight and frog-leg positions? Does a sacral lift improve femoral vein exposure (reduce overlap by the femoral artery) compared to no sacral lift in both straight and frog-leg positions? Researchers will compare femoral vein size and exposure measurements with and without a sacral lift in both straight and frog-leg leg positions to see if the sacral lift improves vein size and reduces artery overlap. Participants will: Undergo femoral vein ultrasound scans. Maintain a straight leg position with and without a sacral lift. Maintain a frog-leg position with and without a sacral lift.

COMPLETED
Optimizing Prevention of Healthcare-Acquired Infections After Cardiac Surgery (HAI)_2
Description

The investigators will conduct qualitative interviews of hospital personnel regarding HAI prevention practices, and use coded data from these interviews to assist in developing standardized practices.