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

NCT03469466 | Unknown

• 1 other identifier: 1190543-1
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (1)

• 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'.

  1 day

Study Arms (3)

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

Diagnostic Test: bedside ultrasound

Interventions

bedside ultrasound DIAGNOSTIC_TEST

bedside ultrasound imaging of the lungs

healthy volunteer

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

volunteers agreeable to consent to study and perform bedside ultrasound imaging

You may qualify if:

• agreeable to consent

You may not qualify if:

• refusal to consent

Sponsors & Collaborators

• Stony Brook University: lead

Study Sites (1)

Stony Brook University Hospital

Stony Brook, New York, 11794, United States

Location

Related Publications (4)

• 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.

  PMID: 23453728 RESULT

• 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.

  PMID: 27634611 RESULT

• 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.

  PMID: 23066623 RESULT

• 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.

  PMID: 28095957 RESULT

Study Officials

• Sahar Ahmad, MD

  Stony Brook University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Department of Medicine

Study Record Dates

• First Submitted: February 13, 2018
• First Posted: March 19, 2018
• Study Start: April 1, 2018
• Primary Completion: December 30, 2018
• Study Completion: December 31, 2018
• Last Updated: September 24, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)