Abdominal PainED RTMUSNCT05635214
Real Time Remote Tele-Mentored Ultrasonography in the ED
An observational study of Abdominal Pain and Flank Pain, run by University of Maryland, Baltimore.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Abdominal Pain, Flank Pain
- What is being tested?
- real time remote tele mentored ultrasound exam
- Type of treatment
- Surgery or procedure
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2023to 1 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: -Patients who present to the emergency department with abdominal pain or flank pain.
Who may be able to join
- Patients who present to the emergency department with abdominal pain or flank pain.
- Age greater than or equal to 18 years
Who cannot join
- Patients who do not present to the emergency department with abdominal pain or flank pain.
- Age less than 18 years
- Unable to consent
About this study
Official title: Real Time Remote Tele-Mentored Ultrasonography to Assist Emergency Medicine Providers at Physician Shortage Designation Hospitals
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.
Read the 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 investigator's 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.
User's Acceptability of RTMUS: In this aim, the investigators will evaluate emergency department user's 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.
- Conditions
- Abdominal Pain, Flank Pain
- Being tested
- real time remote tele mentored ultrasound exam
- Keywords
- ultrasound, telemedicine, emergency medicine
- Medical subject headings
- Abdominal Pain, Flank Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
real time remote tele mentored ultrasound examProcedure or surgery
A patient will have a point of care ultrasound exam performed by a local provider with a remote expert guiding them through the exam using video conferencing.
| Study group | Role | What they receive |
|---|---|---|
| Patients with RUQ or Flank Pain | These are patients who present to the emergency department with abdominal pain or flank pain. Receives: Procedure: real time remote tele mentored ultrasound exam |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with abdominal pain or flank pain in which RTMUS is used
ED patients with chief complaint of abdominal pain or flank pain
Measured: through study completion, an average of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2022
- Study start1 May 2023 (estimated)
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Nov 2023
Why it stopped: Poor community engagement
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Abdominal PainStudies of the same condition, open and under way.
- More trials run by University of Maryland, BaltimoreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexis Salerno, University of Maryland, Baltimore
- Investigators
- Alexis Salerno, MD, Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05635214
- Sponsor's protocol ID
- HP-00104001
- Acronym
- ED RTMUS
- Status last verified
- Nov 2023
- First submitted
- 8 Nov 2022
- Last updated
- 7 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Time Remote Tele-Mentored Ultrasonography to Assist Emergency Medicine Providers at Physician Shortage Designation Hospitals
- ClinicalTrials.gov ID
- NCT05635214
- Acronym / sponsor ID
- ED RTMUS / HP-00104001
- Conditions
- Abdominal Pain, Flank Pain
- Keywords
- ultrasound, telemedicine, emergency medicine
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Poor community engagement
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- 1 May 2023 (estimated)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Nov 2023 (actual)
- First posted
- 2 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 investigator's 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.
User's Acceptability of RTMUS: In this aim, the investigators will evaluate emergency department user's 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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with RUQ or Flank Pain | – | Procedure: real time remote tele mentored ultrasound examThese are patients who present to the emergency department with abdominal pain or flank pain. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- -Patients who present to the emergency department with abdominal pain or flank pain.
Key inclusion criteria (2 listed)
- Patients who present to the emergency department with abdominal pain or flank pain.
- Age greater than or equal to 18 years
Key exclusion criteria (3 listed)
- Patients who do not present to the emergency department with abdominal pain or flank pain.
- Age less than 18 years
- Unable to consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| real time remote tele mentored ultrasound examA patient will have a point of care ultrasound exam performed by a local provider with a remote expert guiding them through the exam using video conferencing. | Procedure or surgery | Patients with RUQ or Flank Pain |
Primary outcome
Number of participants with abdominal pain or flank pain in which RTMUS is used
Time frame: through study completion, an average of 6 months
ED patients with chief complaint of abdominal pain or flank pain
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexis Salerno, MD principal investigator
University of Maryland, Baltimore
Questions about this trial
What is this clinical trial studying?
An observational study of Abdominal Pain and Flank Pain, run by University of Maryland, Baltimore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 7 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with abdominal pain or flank pain in which RTMUS is used (time frame: through study completion, an average of 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2023.