Remotely Guided Ultrasound Among Non-Medical Personnel To Assess Normal Lung Parenchyma

NCT ID: NCT03469466

Last Updated: 2018-09-24

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-04-01
• Study Completion Date: 2018-12-31

Brief 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 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.

Conditions

Healthy Volunteers

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

untrained

Volunteers untrained in bedside ultrasound technique

No interventions assigned to this group

trained

Volunteers previously trained and experienced in bedside ultrasound technique

No interventions assigned to this group

healthy volunteer

Standardized patient who will undergo ultrasound study

bedside ultrasound

Intervention Type: DIAGNOSTIC_TEST

bedside ultrasound imaging of the lungs

Interventions

bedside ultrasound

bedside ultrasound imaging of the lungs

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• agreeable to consent

Exclusion Criteria

• refusal to consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Stony Brook University

OTHER

Sponsor Role: lead

Responsible Party

Sahar Ahmad

Assistant Professor, Department of Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sahar Ahmad, MD

Role: PRINCIPAL_INVESTIGATOR

Stony Brook University

Locations

Stony Brook University Hospital

Stony Brook, New York, United States

Countries

United States

References

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Reference Type: RESULT

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Reference Type: RESULT

PMID: 27634611 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23066623 (View on PubMed)

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.

Reference Type: RESULT

PMID: 28095957 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

1190543-1

Identifier Type: -

Identifier Source: org_study_id