VIDEOS OF SAL BANCHITTA UNDER THE SALSCAN REMOTE CHEST ULTRASOUND PROJECT
ABSTRACT
In response to the many health concerns of the current Covid-19 pandemic, radiologists and imaging technicians worldwide have presented significant demand for portable imaging in “the front lines” -including pandemic treatment centers, emergency care centers and triage facilities. As a result of this demand, hospital bedside ultrasound screening of respiratory & cardiovascular disorders are now expanding in popularity to identify disorders that may be related to Coronavirus pathogen response.
Renamed "the modern stethoscope", the handheld ultrasound provides visual evidence of many organs in their current state or condition. Matching the many field advantages of the portable nature of ultrasound devices with the surge of tele-health/telemedicine solutions, remote training procedures and e-file sharing capabilities supports the future of immediate data access and diagnostic accuracy. This report provides a practical overview of the entire remote screening process while providing a full breakdown on each element of the testing process.
1. INTRODUCTION
In April of 2020, a collaborative research project to explore (and design) a working model for remote ultrasound training and diagnostic evaluation was formed with the hopes of formalizing a future strategy of "virtualizing" technology-based health assessments. Code named "SALSCAN", this concept was formulated between a research strategist & process analyst, a NYC based radiologist, a volunteer patient who tested Covid-19, a portable ultrasound manufacturer* (donor of current portable ultrasound device) and a remote/virtual training specialist to conduct imaging guidance to ensure the patient's proper use of the device. The developers hoped to formalize this protocol as a nationwide scanning alternative during Covid times, as it was first launched in European triage centers to identify covid-related respiratory disorders [1]
The SALSCAN test program was established to review, record and build conclusive evidence of any/all useful information that may lead to, or reflect the strategic paradigms of real-life applications pertaining to the use of remote personal & portable ultrasound.
2. TESTING PARAMETERS
Objectives of the SalScan test program include:
1) Creating a synergistic work model of the 3 integral participants (the patient, the trainer and the overreader/radiologist) to support a future work plan for any and all remote diagnostic scenarios
2) Blueprinting and monitoring the progress of a working model of a medically monitored self-scanning paradigm (including scan diagrams on the torso, selected probes and frequency settings)
3) Developing any and all instructional guidelines to duplicate the process of this plan
4) Selecting and reviewing portable ultrasound technology with easy-to-use controls for ANY patient
5) Tracking the feasibility of a patient-induced tele-training program to capture ultrasound images for medical diagnosis via tele-medicine
6) Challenging the current web-based communication solutions, including conferencing, file sharing, privacy protocols, media player applications and collaboration (group) reporting capabilities
7) Developing a fully-functioning remote training program (through the use of web-based teleconferencing) to guide the patient on the proper/effective use of ultrasound transducers or probes
8) Assessing the actual ‘learning curve’ of the patient to confirm a formatted lesson plan
9) Evaluating the UI (user interface) of the current technology controls to identify patient’s learning success
10) Reviewing, overcoming and problem-solving all obstacles of the remote connection
11) Develop a fully streamlined data transferring/file sharing portal with the overreader (radiologist) to assess and submit a full report of the patient’s condition
12) Producing a quantitative data-gathering screening program from a home-based unit
13) Exploring and confirming the effectiveness of a portable ultrasound as a screening option for any field (non-hospital) situation- ie. battlefields, the ER, ocean liners, ambulances, space programs, natural disasters, etc.
14) Promoting a safety-conscious program to test for contagious pathogens in the safely & comforts of one's own home without health risks from travel
15) Developing a solid 3-point communication system for a real-time remote diagnostic protocol; synergy between patient, trainer and radiologist
16) Opening many more potential patient types, disorders and scenarios for this level of remote scanning access and telemedicine
This self screening program is an opportunity to beta-test key elements of the remote instructional functions and medical diagnostic intervention whereby the project planner can successfully track and explore all procedural responses and the many findings set by the dynamics between the 3 parties: the patient, the radiologist and the remote trainer.
The obstacles of zero physical contact and the scenario of conducting a scan training to the a non-medically familiar individual aimed to draw valuable conclusions dedicated to reproducing this remote screening plan for countless emergency and non-urgent care situations worldwide.
The volunteer patient (Mr. Sal Banchitta) offered his own Covid-test results, his experiences and his complete participation to this technical process research. The program directors were successfully able to conduct a real-time beta test that drafts a complete staging plan on a future of remote virtual ultrasound screening.
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According to Dr Philippe Kory (critical care physician) "When we use an ultrasound on the lungs, we look for something called B LINES. Compare with a base line, the worse your lung ultrasound score was, the higher risk you had of deterioration. It's another type of exam where you could identify the trajectory of a patient, leading to a possible need for an escalation in therapy."
3. ADVANCING THE REMOTE SCAN MOVEMENT & PRE-HOSPITAL ULTRASOUND:
Before Covid-19, TeleMedicine, TeleHospital and other web-based 'tech med' solutions have existed for decades. Teleradiology has been used for over 60 years since film was being passed through a digitizer for direct digital capturing and transmitting globally overnight. [2] This allowed faster response when it comes to head injuries in rural areas and other trauma events where teleradiology vastly improved other applications in diagnosis and treatment planning. Today, expanded evidence of remote imaging appear in areas like space travel, emergency response, military deployments- and pandemics.
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| Emergency response units rely on remote / portable innovations for on-site calls |
Pre-hospital ultrasound is employed in this setting to differentiate reversible causes of pulseless electrical activity (PEA), assess for pericardial, intraperitoneal, and pleural fluid in trauma, and to differentiate between pulmonary edema and emphysema. In the USA, the focus on rapid transport and limiting on-scene time may have contributed to slower adoption of prehospital ultrasound [3]
4. INITIALIZING THE REMOTE SELF-SCREENING CONCEPT AND PROCESS
The patient volunteered himself to be the first test case and self-scanning trainee for a regimen of chest ultrasound scans under the beta-tested REMOTE HOME-SCAN & TELE-RADIOLOGY program. This program adapted key elements of lung ultrasound for a wider set of uses at the safety and comfort of the patient's home for regular ultrasound screening and continued monitoring.
Targets: Provide the patient and overreader and designated radiologist immediate access to a reliable high-frequency PORTABLE ultrasound scans of LUNGS, HEART, LIVER and KIDNEYS (image- R) - the major organs that may show signs of Covid related disorders.
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| The "Body Map" followed by the patient (Sal) marking scan target points of organs as directed by the remote trainer (Mike) |
Virtual (web) access: Through complete remote access, the professional ultrasound trainer (Mike Thury) operates the scanning software (via Teamviewer™) while instructing the patient via video conferencing (Zoom™) on how to properly operate the hand held probes and the ultrasound.
Data Collection Routine: After each scanning session, the patient and trainer shall save all daily scan images collected- both on the portable device and on a cloud-based backup. Once a given number of days has been satisfied, the designated medical radiologist (Dr. Robert L. Bard, NYC) shall access the device to collect & review all image files for a through analysis.
5. REMOTE ULTRASOUND BENEFITS FOR ALL PATIENT TYPES
The constant evolution and upgrades in portable ultrasound innovations has made it possible for any patient undergoing treatment to track their own progress on a regular schedule (from home) without the hindrance of traveling to a doctors office. For patients suffering chronic conditions, personal access to a portable ultrasound with remote access to a designated clinical team represents the next generation of patient diagnostic care. [4]
During his training and scanning period, the patient's participation provided the SALSCAN program with important procedural data toward the foundation for this upcoming national screening initiative. Our program developers' goals aim to support the global use of ultrasound imaging devices for the many non-hospital applications where access to large-format devices are simply not available. Use of the ultrasound can either confirm the patient is in fact asymptomatic, or may prove to be useful as an early detection device by identifying any hidden anomalies.
5.1 Covid-19 is a multifocal, multiorgan disease meaning that a unit would require variable probes and equipment settings. The settings used in this scan series that included the lungs, liver, kidneys and heart utilized safety protocols for mechanical index (MI) and thermal index (TIS) employing curved array probe for lung, liver and kidneys and sector scanner for heart and lungs. Different transducers are available on many units but this study did not involve the application of the linear probe since the regions insonated were appropriately covered by the sector and curved array, or linear transducer if necessary.
5.1.1MI: The Mechanical Index
MI is of possible clinical interest if the beam focus is close to the surface of lung tissue. MI has the following characteristics:
• Potential bioeffect: Any possible mechanical or non-thermal mechanisms - although the likelihood of adverse consequences from these causes is not well understood, such risk may be highest in the presence of gas-saturated structures such as lung tissue.
• Mode type: Calculated for all modes of operation.
• Tissue type and location: Soft tissue at all locations in the scan field.
• Acoustic parameter: Maximum negative (rarefactional) ultrasound pressure at focus.
5.1.2 TIS: The Soft Tissue Thermal Index
TIS is of interest in the absence of bone, either at the tissue surface or near the beam focus. Applications of clinical interest include general abdominal examinations, first-trimester scanning before fetal bone has ossified, and cardiology. TIS has the following characteristics.
• Potential bioeffect: Thermal heating of soft tissue due to absorption of ultrasound. The TIS value is the ratio of the current probe power to the reference level that would cause
a 1ºC temperature rise in soft tissue.
• Mode type: Relevant for all modes, in both scanned and non-scanned modes.
• Tissue type and location: In scanned modes, soft tissue at the surface is of concern. In non-scanned modes, heating of soft tissue along the beam axis between the surface and focus is considered.
• Acoustic parameters: For scanned modes, the associated intensity at the surface is usually related to surface tissue heating. For unscanned modes, the maximum derated power through a 1-cm2 area anywhere along the beam axis is the basis for estimating tissue heating: unscanned beams less than 1cm2 in area at the surface are assumed to contribute only to surface heating, and the calculated effects are combined with those of scanned modes to estimate total soft-tissue heating at the surface. Unscanned beams larger than 1 cm2 at the surface are assumed to heat tissue only near the focus. Total heating effects at the surface and focus are compiled separately, and the larger value is
reported as TIS.
5.2 the role of the patient includes turning on the unit and applying gel to the areas to be scanned. Wifi internet is activated for real time connectivity. The sonogram unit activated by the patient will then be used by the remote trainer through video or audio/video conferencing to guide the procedure
5.3 the role of the remote trainer/technician is to view the probe position on the patient and adjust the perpendicularity of the sound beam on the televised image VIDEO ????? Breathing and other respiratory maneuvers may be adjusted at this time such as investigation of the inferior vena cava when pericardial effusion is discovered or aberrant ventricular wall motion is present. All imaging functions of the probe such as patient ID input, M mode, Doppler, video are remotely carried out by the trainer during the live scanning session. Routinely 2-5 second videos are recorded for review and verification of the event.
5.4 The role of the physician radiologist is to verify the image quality, probe placement, depth of penetration and confer with the trainer if adjustments are necessary. Ideally this interaction occurs at the initial or second visit. Most patients will have normal findings therefore 12 hour intervals is adequate for observation. Any aggravation of the symptoms (dypnea, palpitation, oxygen concentration decrease) calls for 4 hour scan intervals and real time physician input. Adverse outcomes may occur at any time and in any organ system. It is recommended that the heart, liver and renal structures be interrogated daily as well since delayed onset of ventricular inflammation (myositis) or large vessel thromboembolic phenomena are increasingly common. If neurologic sequelae occur the linear probe may image the carotid artery in the neck and the ophthalmic artery/vein complex. The sector or phased array cardiac probe has sufficient penetration to assess the intracranial arteries (transcranial Doppler ultrasound) and check for impending stroke or venous thrombosis.
5.5 Overall pulmonary function clinical assessment relates to the A-lines and B-lines. The high percentage of normal pleural A-line appearance implies that there is no significant pleuro-pulmonary pathology as is expected in patients on bedrest. B-line increase may call for hospitalization while the conversion of B-lines to A-lines highlights improvement. Bedside point of care remote diagnostic criteria are not available for non pulmonary organs. In the “sal scan” project A-line pattern was uniform for 14 days and our patient returned to normal activity. He is currently donating his plasma for the benefit of others.
6 REMOTE CT AND SONOGRAM FUSION DIAGNOSTICS
After initial experience with the outpatient remote ultrasound program, the scope moved to remote CT reviews and finally, combined reporting of lung ultrasound with lung CT with the option of image guided treatment using fusion of both modalities (fusion is covered in chapters 3 and 8) at distant locations throughout the United State on inpatients. On one encounter during the month of June, remote CT review by a radiologist supported the clinical impressions by overworked clinical colleagues.
Below are the pertinent data:
6/24/20 CT INITIAL FILM FOLLOW UP
THICKENED PLEURA 5/5 1/5
GROUND GLASS OPACITY (GGO) 5/5 2/5
SUBPLEURAL CONSOLIDATON 5/5 1/5
TRANSLOBAR CONSOLIDATION 5/5 0/5
MULTILOBAR CONSOLIDATION 5/5 0/5
PLEURAL EFFUSION N/A 0/5
KORY #5 BEFORE AFTERDATE REPORT
Kory arrows traction bronchiectasis
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SALSCAN PROJECT- STATEMENT OF CONCLUSION
1) The SalScan Remote Screening project started on April 15, 2020 for six (6) consecutive days. It collected complete ultrasound video images of the patient's Lungs (from various angles), heart, liver and kidneys each day.
2) As of June 1, 2020, the SalScan project concluded its imaging, multi-testing and research efforts showing a non-symptomatic Covid Positive case. This supports conclusive data available in current medical reports from nationwide testing.
3) The SalScan project integrated the results of the patient's (1) original Covid test and (2) an independent AntiBody test.
* The Covid Positive test result assumed the connection with the patient's heavy Flu-like and respiratory symptoms in early January-Feb. and may have functionally recovered by April as our imaging scans have indicated no present physical traces of pathogen response in the major organs scanned
* The patient's recent antibody test indicated positive (+) results, suggesting the validity of the initial Covid test and its diagnostic result. Based on current scientific reports, this presence of antibodies suggest a likelihood of infection by Covid-19 pathogens in the recent past and that the patient's immune system has built up a protein defense to fight the virus. (image below)
* Our 6-day scan series recognizes his path to recovery (from his noted symptoms from earlier months) as images gathered on April, 2020 have concluded NO visual trace of pathogen response or infections.
4) The SalScan Program was designed as a PILOT to beta-test the blueprint of future Chest Ultrasound Screening, Remote Personal Screening and Virtual Overreading programs.
5) The SalScan Pilot successfully supported the comprehensive breakdown of the 3-member virtual/remote diagnostic paradigm, whereby this test proves the ease of use of the device and its comprehensive application of web-based communication and file sharing technology.
6) As the SalScan volunteer patient continued to maintain a non-symptomatic state (after July) under a twice confirmed Covid Positive test diagnoses, initiating the use of a personal ultrasound screening helped validate the patient's recovery and/or non-critical status. This also provided necessary peace of mind to the patient seeking to affirm the direction of his clinical test results.
7) Additional imaging studies, medical (lab) reports and peer-reviewed data shall continue on a quarterly basis due to any possible recurrence that may arise. Probability of recurrence has been clearly documented in recent medical journals and news reports.
8) The current pandemic and the growing list of treatment communities are poised to receive this report as part of Dr. Robert Bard's global advocacy to expand the medical use of portable ultrasound in "the front lines" of health responders community.
9) The SalScan virtual remote self-screening protocol, its staging plans, chest ultrasound mapping, scheduling and training process is a comprehensive program design that can be translated to serve any individual undergoing critical care, patients who are recovering from treatments at home or are in remote areas where regular radiology visits may prove to be a hardship to the patient.
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| "Remote Personal Imaging" (L-R): Sal Banchitta, Actual heart scan image | Mike Thury (remote technical trainer, Terason Ultrasound) Len Gettz- program dir. | Dr. Robert Bard- monitoring radiologist |
Resources:
1) Global Medical Allies Share Lung Ultrasound Solution for COVID-19 Triage | ITN Imaging Technology news (April 6, 2020) https://www.itnonline.com/content/global-medical-allies-share-lung-ultrasound-solution-covid-19-triage
2) The Evolution of Telehealth: Where Have We Been and Where Are We Going? - https://www.ncbi.nlm.nih.gov/books/NBK207141/ Copyright 2012 by the National Academy of Sciences. All rights reserved.
3) Use of ultrasound by emergency medical services: a review | US Natl. Library of Medicine (PMC)- Nov, 2011: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2657261/
4) Recent Developments in Tele-Ultrasonography | US Natl. Library of Medicine (PMC) Apr-Jun, 2018 : https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6320468/
ROBERT L. BARD, MD, PC, DABR, FASLMS
Project Overreader- Advanced Imaging & Diagnostic Specialist
Dr. Bard received the 2020 nationally acclaimed Ellis Island Award for his lifetime achievement in advanced cancer diagnostic imaging. He co-founded the 9/11 CancerScan program to bring additional diagnostic support to all first responders from Ground Zero. His main practice in midtown, NYC (Bard Diagnostic Imaging- www.CancerScan.com) uses the latest in digital imaging technology and has been also used to help guide biopsies and in many cases, even replicate much of the same reports of a clinical invasive biopsy. Imaging solutions such as high-powered sonograms, Power Doppler Histogram, sonofluoroscopy, 3D/4D image reconstruction and the Power Doppler Histogram are safe, noninvasive, and do not use ionizing radiation.
MICHAEL THURY, RDCS, RVT, FASE
Michael is the current Global Product Manager for Terason Ultrasound (Burlington, MA). Commercially he has spent the last 19 years training physicians, clinicians and distribution partners around the world on the uses and benefits of ultrasound. He has been recognized numerous times for outstanding clinical and sales excellence both at Terason and GE Healthcare. Michael holds a AAS in Cardiovascular Technology from Southeast Technical College and is a South Dakota native.
PIERRE KORY, M.D., M.P.A.
He served as the Medical Director of the Trauma and Life Support Center at the University of Wisconsin where he was an Associate Professor and the Chief of the Critical Care Service. He is considered a pioneer and national/international expert in the field of Critical Care Ultrasound and is the senior editor of the widely read textbook “Point-of-Care Ultrasound” (winner of the President’s Choice Award for Medical Textbooks from the British Medical Association in 2015). Most recently, Dr. Kory joined the emergency volunteer team during the early COVID-19 pandemic in NYC at Mount Sinai Beth Israel Medical Center. He is also a founding member of the Front Line COVID-19 Critical Working Group (flccc.net) composed of 5 critical care experts that devised the COVID-19 treatment protocol called MATH+. (www.covid19criticalcare.com/)
* TERASON ULTRASOUND: donor of the 3200T remote / portable ultrasound device used in this beta test.
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