Remotely Guided Ultrasound Among Non-Medical Personnel To Assess Normal Lung Parenchyma
Conditions: Healthy Volunteers
Sponsor: Stony Brook University

Remotely Guided Ultrasound Among Non-Medical Personnel To Assess Normal Lung 
Parenchyma 
 
3/15/2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

TITLE:  Remotely Guided Ultrasound Among Non-Medical Personnel To Assess Normal Lung 
Parenchyma 
  
INVESTIGATORS: Quinn Dufurrena MD, Sahar Ahmad, MD (PI) 
  
 
A. SPECIFIC AIMS 
The aim of this study is to determine whether non-medical personnel, with no experience in 
ultrasound (US) use can effectively utilize the technology with remote guidance by expert 
assistance to assess for normal lung parenchyma among healthy volunteers.  
  
B. BACKGROUND AND SIGNIFICANCE 
US has become an increasingly utilized modality in the healthcare setting. Advances in US 
technology and a burgeoning field of research showing its efficacy has rendered US a crucial 
tool in such fields as emergency and critical care medicine. The portability and ease of use of 
US has led to its use in the fields of wilderness, polar and aerospace medicine as well. Portable 
US machines have been taken on mountaineering expeditions and launched to the International 
Space Station, at which times it has been used to diagnose high altitude pulmonary edema and 
monitor intracranial pressure among astronauts, respectively (Wimalasena et al 2013, Lerner et 
al 2016). Emergencies in remote environments such as space may necessitate the use of US 
by non-medical personnel, at which time the data gathered would be transmitted to medical 
professionals to be analyzed and upon which clinical decisions would be made. Small studies 
have shown the effectiveness of utilizing non-medically trained personnel in obtaining adequate 
US images for such evaluations as optic nerve sheath diameter and carotid artery dynamics 
(Martin et al 2012).  
Extreme environments such as space, expose those in it to such risks as depressurization, 
which can lead to multiple lung pathologies such as pulmonary edema and/or pneumothorax 
(Galdamez et al 2017). In such circumstances, remotely guided ultrasound may prove crucial to 
quickly identifying such medical complications of extreme environments. This initial pilot study 
will determine the feasibility of using remotely guided ultrasound among non-medical personnel 
on healthy volunteers to identify normal lung parenchyma by identifying commonly used 
indicators of such (e.g. lung-sliding, a-lines). If the results of the study indicate that such 
operations are feasible, further investigations into whether non-medical personnel are able to 
identify lung pathologies among confirmed cases of such conditions as pulmonary edema or 
pneumothorax may be pursued.  
 
C. RESEARCH DESIGN AND METHODS 
1. Rationale/overview 
This study will assess the feasibility of remotely guided US use by individuals without ultrasound 
training to assess for normal lung parenchyma in healthy volunteers (patients) and amongst 
themselves. The untrained operators (operators) will perform US examinations of the lung under 
the guidance of a medical professional (expert) with experience in ultrasound technique. During 
the first portion of the study, the professional will guide the operator step by step on how to 
conduct an US exam of the ‘patient’s’ lung. This simulation will be analogous to an untrained US 
operator assessing a potentially ill patient with the assistance of a remotely located physician. 

The second portion of the study, during which time the participant will carry out an US exam on 
themselves, would be analogous to a lone patient in possession of US technology carrying out a 
self-examination under similar guidance of an expert. During both parts of the studye images 
will be saved and reviewed at a later time by an ultrasound expert to determine quality and 
clinical functionality in recognizing normal lung parenchyma. Images obtained by ‘operators’ will 
be compared against those obtained by US-trained clinicians (clinicians) captured from the 
same ‘patient’. Real world examples of these scenarios would include an astronaut with 
respiratory distress after experiencing a rapid decompression event being evaluated by another 
healthy astronaut (or by themselves as in the second scenario) by US under the guidance of the 
flight surgeon at Mission Control.  
 
2. Research Site 
The study will be conducted at the Clinical Skills Center (CSC) at Stony Brook University School 
of Medicine (SBU) 
 
3. Study sample 
A convenience sample of 20 healthy volunteers will be recruited from the Stony Brook 
undergraduate campus to participate as ‘operators’ in the study. ‘Patients’ will be recruited from 
a pool of standardized patient models who regularly participate in activities in the CSC. 10 US-
trained clinicians will be recruited from SBU. 
 
4. Screening 
Healthy volunteers will be recruited from the Stony Brook undergraduate campus. They will be 
screened for prior medical training, particularly regarding US technique. Those with any amount 
of US training and more than minimal medical/nursing training will be ineligible for participation.    
 
5. Procedures 
Volunteers will meet with study personnel in the CSC at SBU. Informed consent will be obtained 
from all groups (‘operators’, ‘patients’, ‘clinicians’).  A survey will be conducted to evaluate the 
subjects’ prior experience in ultrasound.  Subjects who qualify will continue to participate in the 
study.  
The ‘patient’ will initially be evaluated by US by an expert and ‘ideal’ images will be captured 
and stored for later comparison against those obtained by ‘operators’.  
The ‘operator’ will be given an smart phone/table with video communication function and will be 
connected with the US ‘expert’, who will be located in a different room, physically and audibly 
out of range. For the first portion of the study, the ‘expert’ will instruct the ‘operator’ on how to 
conduct an US exam limited to the lung. Using the two-way video and audio communication 
through the video communication application, the expert will guide to the operator on how to 
utilize the US machine, where to place the probe, and how to capture and save images. The 
‘patient’ will be instructed not to assist the ‘operator’ in any way. For the second portion of the 
study, the ‘operator’ will utilize the US machine to conduct a similarly limited lung exam on 
themselves, again with the assistance of the ‘expert’ but no other study personnel.  

Finally, the ‘clinicians’ will carry out similarly limited lung exams on the ‘patient’, first without 
instruction from the ‘expert’ and then again under similar guidance as the previous portions of 
the study.  
During all portions of the study, time to image capture will be measured by observing personnel. 
All captured images will be sent to expert reviewers at which time a quality score will be 
generated. Ultrasound experts will blindly evaluate images obtained from both untrained and 
trained groups. Using the 'Ultrasound Quality Scorecard', evaluators will assess the quality of 
the image obtained and the technique carried out to obtain the image. These quality and 
technique criteria include 'Discernable Lung Parenchyma', 'Presence of A-lines', 'Lack of 
Obstruction from Rib Shadowing', 'Correct Probe Selection', Correct Depth Setting', 'Correct 
Gain Selection'. For each criterion (both quality and technique), a binary 'Yes/No' score will be 
given. Total 'Yes' scores will be summed for each ultrasound exam (minimum 0, maximum 6), 
with the higher number of 'Yes' responses signifying a higher quality ultrasound exam. Each 
ultrasound exam will be scored by three separate experts, with the average of the three scores 
being reported as the 'Final Score'. Reviewers will be comprised of three experts in the field of 
US, all MDs who have received formal training in US and have at least 5 years of clinical US 
practice experience. Each captured image will be reviewed and scored by all three reviewers. 
  
D.  STATISTICAL ANALYSIS PLAN 
‘Final Scores’ determined from the score sheets will be compared between the ‘operators’ and 
‘clinicians’.  
Mean scores of the two groups will be reported, with their respective standard deviations.  
Student’s T-Test will be carried out to assess difference between the two groups.  
All hypothesis testing will be carried out using two-sided 5% significance level. 
 
E. FUNDING STATUS, DETAILS 
This project will not receive any funding.  
          
F.  HUMAN SUBJECTS RESEARCH PROTECTION FROM RISK 
  
Risk to Subjects/Adequacy of Protection Against Risks- 
US is a safe and non-invasive diagnostic modality and poses no physical risk to participants in 
the study. Psychological risk is minimal but not absent, as a participant may discover abnormal 
lung physiology or pathology that may cause psychological harm. 
Risk is minimal in this project, no additional protection against risk is necessary. 
  
Potential Benefits of Proposed Research to the Subjects and Others/Importance of the 
Knowledge to be Gained- 
There will be no benefits to participants involved in the study. We anticipate that this study will 
provide important information regarding the feasibility and utility of remotely guidance ultrasound 
use on patients in remote settings in the absence of trained medical personnel. The results of 
this study will contribute to a growing body of ultrasound research. 
  
G.   DATA SAFETY MONITORING PLAN (for more than minimal risk studies) 

Unnecessary for this study 
 
G.  LITERATURE CITED 
 
Wimalasena Y, Windsor J, Edsell M. Using ultrasound lung comets in the diagnosis of high 
altitude pulmonary edema: fact or fiction? Wilderness Environ Med. 2013 Jun;24(2):159-64. doi: 
10.1016/j.wem.2012.10.005. Epub 2013 Feb 28. Review. PubMed PMID: 23453728. 
  
Lerner DJ, Parmet AJ, Don S, Shimony JS, Goyal MS. Technique for Performing Lumbar 
Puncture in Microgravity Using Portable Radiography. Aerosp Med Hum Perform. 2016 
Aug;87(8):745-7. doi: 10.3357/AMHP.4601.2016. PubMed PMID: 27634611. 
  
Martin DS, Caine TL, Matz T, Lee SM, Stenger MB, Sargsyan AE, Platts SH. Virtual guidance 
as a tool to obtain diagnostic ultrasound for spaceflight and remote environments. Aviat Space 
Environ Med. 2012 Oct;83(10):995-1000. PubMed PMID: 23066623.  
 
Galdamez LA, Clark JB, Antonsen EL. Point-of-Care Ultrasound Utility and Potential for High 
Altitude Crew Recovery Missions.Aerosp Med Hum Perform. 2017 Feb 1;88(2):128-136. doi: 
10.3357/AMHP.4640.2017. Review. PubMed PMID: 28095957.