Remotely Guided Ultrasound Among Non-Medical Personnel To Assess Normal Lung Parenchyma
Status: | Enrolling by invitation |
---|---|
Conditions: | Healthy Studies |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 9/26/2018 |
Start Date: | April 1, 2018 |
End Date: | December 31, 2018 |
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.
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.
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.
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.
Inclusion Criteria:
- agreeable to consent
Exclusion Criteria:
- refusal to consent
We found this trial at
1
site
Click here to add this to my saved trials