- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03469466
Remotely Guided Ultrasound Among Non-Medical Personnel To Assess Normal Lung Parenchyma
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Volunteers will meet with study personnel in the Clinical Skills Center at Stonybrook University. 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. The score will be generated based off of the clinical utility of the image, general image quality, and several technical components of the image. Please see the accompanying Score Sheet for further details. Reviewers will be blinded as to the origin of the images ('operator' vs. 'clinician'). Scores obtained from 'operators' will be compared against those of 'clinicians'. 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.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Locations
-
-
New York
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Stony Brook, New York, United States, 11794
- Stony Brook University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- agreeable to consent
Exclusion Criteria:
- refusal to consent
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
untrained
Volunteers untrained in bedside ultrasound technique
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|
trained
Volunteers previously trained and experienced in bedside ultrasound technique
|
|
healthy volunteer
Standardized patient who will undergo ultrasound study
|
bedside ultrasound imaging of the lungs
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Ultrasound Image Quality
Time Frame: 1 day
|
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'.
|
1 day
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Sahar Ahmad, MD, Stony Brook University
Publications and helpful links
General Publications
- 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.
- 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.
- 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. doi: 10.3357/asem.3279.2012.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 1190543-1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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