Viewing Study NCT05635214



Ignite Creation Date: 2024-05-06 @ 6:21 PM
Last Modification Date: 2024-10-26 @ 2:46 PM
Study NCT ID: NCT05635214
Status: WITHDRAWN
Last Update Posted: 2023-11-07
First Post: 2022-11-08

Brief Title: Real Time Remote Tele-Mentored Ultrasonography in the ED
Sponsor: University of Maryland Baltimore
Organization: University of Maryland Baltimore

Study Overview

Official Title: Real Time Remote Tele-Mentored Ultrasonography to Assist Emergency Medicine Providers at Physician Shortage Designation Hospitals
Status: WITHDRAWN
Status Verified Date: 2023-11
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Poor community engagement
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: ED RTMUS
Brief Summary: The goal of this pilot study is to evaluate the use of real time remote tele-mentored ultrasound in the emergency department at hospitals with physician shortage designation The main question the investigators aim to answer is

Will RTMUS be used in instances where it is available and indicated for abdominal pain or flank pain
Detailed Description: Point-of-care-ultrasound POCUS decreases time for clinical diagnosis and improves provider diagnostic accuracy The use of the Focused Assessment with Sonography in Trauma FAST has decreased time to surgical intervention by over 50 for hypotensive trauma patients POCUS also improves resource utilization reducing the 6-month ionizing radiation exposure in patients with suspected renal colic in one study Despite advances in deploying POCUS the remaining gap is an adequate number of emergency department providers who feel confident in performing POCUS examinations limiting the delivery of healthcare services to patients at the point of care Real time remote tele-mentored ultrasound RTMUS can overcome this practice gap by enabling remote ultrasound experts to provide real-time assistance to bedside providers using a telemedicine platform Preliminary studies at the investigators institution have demonstrated the feasibility of deploying RTMUS to guide nurses in the intensive care setting to acquire accurate images suitable for complex clinical decision making In this preliminary study RTMUS had good concordance 90-100 between radiological transthoracic echocardiography or CT for evaluating cardiac findings such as left ventricular function right ventricular dysfunction and pericardial effusion The overall objective of this study is to examine the impact of RTMUS integration to emergency departments in hospitals with physician shortage designations The investigators hypothesize the RTMUS system will be able to provide images sufficient for clinical diagnosis and that the local ED providers will accept RTMUS as a suitable option for ultrasound

Users Acceptability of RTMUS In this aim the investigators will evaluate emergency department users acceptability of RTMUS for abdominal pain and flank pain The investigators hypothesize that in eligible patients RTMUS will be used in at least 10 of the instances in which it is available and indicated As a secondary data point stakeholder surveys will be collected on the use and performance of RTMUS

RTMUS is an innovative solution that can improve patient care This project will engage emergency department providers at physician shortage designation hospitals to increase the use of POCUS in their clinical practice In the future RTMUS can be applied to various resource constrained settings to help providers use POCUS to care for their patients

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None