4 Clinical Trials for Various Conditions
The primary objective of this study is to evaluate the feasibility of a novel app to facilitate heart failure patients to acquire lung ultrasound images and evaluate the quality of those images to expert scans, and to evaluate for relationships between the ultrasound data and pulmonary pressure data from the Abbott CardioMEMS system.
This is a Phase I study to assess feasibility. There will be no impact on clinical care based on this study. The ultrasound system is FDA approved and could be used for clinical care independent of this research study. When a subject receives an ultrasound examination as part of standard of care or within another clinical research trial, such an examination may serve for an intra-individual comparator examination between conventional and new, ultra-portable ultrasound imaging. Patients will be identified in the clinical setting when appropriate and will be appropriately approached for consent for a combination of ultrasound with the physical exam, for medical student education, IV access, and novel application. Patients will be enrolled and accounted for in the appropriate sub-population. Additionally, to understand the impact of ultraportable ultrasound, survey tools will be used to understand the workflow and clinical care applications and integration of these devices. All staff and student members will be appropriately consented; however, the investigators anticipate that this portion of the study will be minimal risk with online consent waivers. Finally, the volunteer population will allow us to practice the use of this equipment and understand the limitations and applicability. The results will be the images acquired as well as surveys from the volunteers and those performing the scans, who will be enrolled in the staff population of this study. No significant risk is identified for subjects in this study. The largest risk, although still minimal, is an incidental finding. For this study, subjects will have the choice if they would like to be informed of an incidental finding. Reporting of incidental findings will be conducted by designated study staff after appropriate consultation and examination of the images by the PI or designee. While there are no direct benefits for subjects in this study, the study hopes to improve the implementation of ultrasound into the clinical setting into the future. This Phase I study aims to examine the feasibility of implementation and the impact on the clinical setting. Additionally, this study hopes to examine the utility and usefulness of ultrasound in medical education and thereby hopes to improve the physical exam skills of clinicians for the future.
Transthoracic echocardiography (TTE) represents an established and fundamental tool for the evaluation of patients with known or suspected cardiovascular disease. Recently, manufacturers have developed handheld echocardiograms small enough to fit in the pocket of a physician's lab coat. Studies assessing these handheld devices have several limitations. While they have generally evaluated the handheld devices favorably, previous studies has not consistently studied handheld devices under the best possible clinical conditions and have not necessarily highlighted the devices' limitations. In this proposal, we seek to analyze the applicability of handheld echocardiograms to standard clinical practice. The investigators plan to use trained sonographers to perform handheld examinations on patients referred for TTE without established cardiovascular disease. The handheld images will be interpreted by experienced, consultant-level echocardiographers. The investigators then plan to compare findings from the handheld echocardiogram to the patient's standard clinical TTE.
This study would be the first to demonstrate feasibility, accuracy, reliability, clinical care impact, and patient satisfaction with remote monitoring of post-void residual bladder volume (PVR) using the Butterfly portable ultrasound device in patients with obstructive voiding dysfunction.