10 Clinical Trials for Various Conditions
This study will examine the use of the ivWatch Model 400 to monitor PIV sites in pediatric patients. Half the participants will be monitored by the device without infiltration notifications and the other half will be monitored by the device with infiltration notifications enabled.
The purpose of this study is to investigate the safety and efficacy of an optical device designed and developed for monitoring the intravenous infusion site for infiltration. The hypothesis is that the changes in optical signals measured near the infusion site using the optical device can be used to monitor intravenous infusion for infiltration.
PET (Positron Emission Tomography) images are used to help make patient management decisions in staging and treatment assessment, often after a cancer diagnosis. Improper injections of PET tracers (dye) may occur approximately 15% of the time. This is known as extravasation or infiltration, and it compromises the doctor's ability to read the PET image. Often, the site where the tracer is injected into the vein (usually in the inside of the elbow) are not in the images taken, so reading physicians are unaware that an extravasation or infiltration has occurred. Technology exists to capture time activity curves (amount of tracer in a location over a period of time) during the PET tracer uptake period (usually once the tracer is injected, the tracer circulates for 60 minutes prior to images), which can enable physicians to accurately detect extravasations and infiltration. This information is currently unavailable to physicians reading routine PET/CT (computed tomography) scans. Time activity curves information gathered from these sensors during the circulation period appear to match the brief pictures taken approximately 70 minutes after the tracer injection. This study will determine if these time activity curves correspond to PET images of the injection site taken during the tracer uptake period. If time activity curves correspond to PET images, they can be used to determine if the tracer was properly injected. If there was an improper injection, clinicians can be alerted to this fact and interpret the image with this additional information.
The purpose of this study to to monitor the peripheral intravenous (PIV) site on subjects receiving continuous IV fluids for infiltration and extravasation events. Infiltration is an indication that the PIV is leaking fluids outside of the vascular system. The study hypothesis is to demonstrate that changes in the optical signals of the non-invasive monitoring medical device will detect infiltration and extravasation events.
This study evaluates a Non-invasive Thermal Infusion Site Monitor (NTISM) device when used during routine outpatient infusion treatments.
This comparative treatment study aims to challenge a current clinical practice. Specifically, whether the use of ultrasound-guided peripheral intravenous catheter insertion results in lower post insertion failure rates with longer utility time compared to peripheral intravenous catheters (PIVC) inserted in the standard manner during the emergency department (ED), observation and in-patient stay. There are two secondary aims to the study: a) determining if ultrasound-guided peripheral intravenous catheter insertion results in lower post removal complication rates compared to PIVCs inserted in the standard manner; and b) determining if catheter-to-vein ratio can predict post insertion success of PIVCs and what catheter-to-vein ratio is most successful. In this study, catheter-to-vein ratio is defined as the diameter of the lumen of the vein divided by the outside diameter of the catheter.
A widely used semi-quantitative parameter to assess tumor status is the standardized uptake value (SUV). SUV estimation accuracy can be impacted by many variables. Today there still exists a significant amount of variability in PET/CT results in test and re-test studies. This variability can be introduced by instrumentation and subject-specific factors. Variability reduces image quality and increases the required changes in tumor quantification to reflect real tumor response or progression. PET/CT scanning process requires that the entire net injected dose of radiolabeled tracer is administered intravenously as a bolus. The quality and quantification of a PET/CT image is highly dependent on the uptake of radiolabeled tracer. Boellaard et al. have indicated infiltrations could potentially underestimate SUV measurements by as much as 50%. Infiltrations and obstructions are not uncommon. Recent studies using a novel QA/QC tool (LaraTM System) for the radiotracer injection process revealed that current means to detect infiltration do not completely identify all infiltrations/obstructions. Since infiltrations may not be visible in the standard field of view (FOV) and since the impact of a peripheral circulatory obstruction may not be visible even if an injection site is in the FOV, it is possible for reading and treating physicians to be unaware that a patient's image and quantification has been impacted. Additionally, when current means do detect an infiltration, they under-represent the severity because they are not capturing that infiltrations often resolve during the uptake period. As a result, infiltrations or obstructions may cause SUV inaccuracy and could adversely impact staging and tumor assessments. The purpose of this study will be to characterize the impact of moderate or greater infiltrations on standardized uptake values. Patients experiencing a moderate or greater infiltration on a routine clinical PET scan will be invited to return for a repeat scan with injection performed by specially trained personnel to reduce the risk of repeat infiltration. The two scans will be compared to assess for changes in tumor uptake intensity.
A single arm trial consisting of 70 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing infiltrated tissues at common sites for peripheral IV therapy.
A single arm study of 40 adult volunteers to assess the safety and efficacy of the ivWatch Model 400 when observing non-infiltrated (normal) tissues at common peripheral IV therapy sites.
Objective: To evaluate color Doppler flow ultrasound compared to standard clinical techniques, to detect the correct position of peripheral intravenous catheters in adult surgical patients. Methods: A prospective study is conducted in adult (\>18 years old) patients scheduled to undergo elective surgery. Peripheral intravenous catheter position is evaluated with standard clinical techniques (free flow of fluid from a hanging bag, easy saline injection, and aspiration of blood), and with color flow Doppler ultrasound proximal to the insertion site. Comparative test performance is carried out.