Healthy VolunteersNCT03469466
Remotely Guided Ultrasound Among Non-Medical Personnel To Assess Normal Lung Parenchyma
An observational study of Healthy Volunteers, run by Stony Brook University at 1 site in United States.
Trial summary
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. The untrained operators (operators) will perform US examinations of lung under the guidance of a medical professional (professional) with experience in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- bedside ultrasound
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2018to 31 Dec 2018
- 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: volunteers agreeable to consent to study and perform bedside ultrasound imaging
Who may be able to join
- agreeable to consent
Who cannot join
- refusal to consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Stony Brook University Hospital
Stony Brook, New York, 11794
About this study
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. The untrained operators (operators) will perform US examinations of lung under the guidance of a medical professional (professional) with experience in ultrasound technique. The professional will guide the operator step by step on how to conduct an US exam of the 'patient's' lung. Images will then be saved and reviewed at a later time by an ultrasound expert to determine quality and clinical functionality in recognizing normal lung parenchyma. This simulation will be analogous to an untrained US operator assessing a potentially ill patient with the assistance of a remotely located physician. An example of this would be an astronaut with respiratory distress after experiencing a rapid decompression event being evaluated by another healthy astronaut by US under the guidance of the flight surgeon at Mission Control.
Read the 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.
- Conditions
- Healthy Volunteers
- Being tested
- bedside ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bedside ultrasoundDiagnostic test
bedside ultrasound imaging of the lungs
| Study group | Role | What they receive |
|---|---|---|
| untrained | Volunteers untrained in bedside ultrasound technique | |
| trained | Volunteers previously trained and experienced in bedside ultrasound technique | |
| healthy volunteer | Standardized patient who will undergo ultrasound study Receives: Diagnostic Test: bedside ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ultrasound Image Quality
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'.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2018
- Study start1 Apr 2018
- Primary completion30 Dec 2018 (estimated)
- Study completion31 Dec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stony Brook University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sahar Ahmad, Stony Brook University
- Investigators
- Sahar Ahmad, MD, Principal investigator, Stony Brook University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03469466
- Sponsor's protocol ID
- 1190543-1
- Status last verified
- Sep 2018
- First submitted
- 13 Feb 2018
- Last updated
- 24 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 23453728Lerner 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 27634611Martin 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.
PubMed 23066623Galdamez 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.
PubMed 28095957
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Remotely Guided Ultrasound Among Non-Medical Personnel To Assess Normal Lung Parenchyma
- ClinicalTrials.gov ID
- NCT03469466
- Acronym / sponsor ID
- 1190543-1
- Conditions
- Healthy Volunteers
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Stony Brook UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Dec 2018 (estimated)
- Study completion
- 31 Dec 2018 (estimated)
- First posted
- 19 Mar 2018 (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.
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. The untrained operators (operators) will perform US examinations of lung under the guidance of a medical professional (professional) with experience in ultrasound technique. The professional will guide the operator step by step on how to conduct an US exam of the 'patient's' lung. Images will then be saved and reviewed at a later time by an ultrasound expert to determine quality and clinical functionality in recognizing normal lung parenchyma. This simulation will be analogous to an untrained US operator assessing a potentially ill patient with the assistance of a remotely located physician. An example of this would be an astronaut with respiratory distress after experiencing a rapid decompression event being evaluated by another healthy astronaut by US under the guidance of the flight surgeon at Mission Control.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| untrained | – | –Volunteers untrained in bedside ultrasound technique |
| trained | – | –Volunteers previously trained and experienced in bedside ultrasound technique |
| healthy volunteer | – | Diagnostic Test: bedside ultrasoundStandardized patient who will undergo ultrasound study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- volunteers agreeable to consent to study and perform bedside ultrasound imaging
Key inclusion criteria (1 listed)
- agreeable to consent
Key exclusion criteria (1 listed)
- refusal 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 |
|---|---|---|
| bedside ultrasoundbedside ultrasound imaging of the lungs | Diagnostic test | healthy volunteer |
Primary outcome
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'.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2018.
- Results publication: PubMed 23453728Wimalasena 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.
- Results publication: PubMed 27634611Lerner 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.
- Results publication: PubMed 23066623Martin 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.
- Results publication: PubMed 28095957Galdamez 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.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
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.
Sahar Ahmad, MD principal investigator
Stony Brook University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Volunteers, run by Stony Brook University at 1 site in United States.
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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
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?
Ultrasound Image Quality (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03469466, which also lists 4 linked publications.
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 24 Sep 2018.