Comparing an Inexpensive Handheld Ultrasound Machine and a Large Mobile Ultrasound System
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 12/9/2018 |
| Start Date: | October 23, 2018 |
| End Date: | October 11, 2019 |
| Contact: | Antonio Gonzalez, MD |
| Email: | antonio.gonzalez-fiol@yale.edu |
| Phone: | 413 386 9415 |
Ultrasound Image Quality Comparison Between an Inexpensive Handheld Ultrasound Machine and a Large Mobile Ultrasound System
To assess the quality of images and diagnostic ability of a handheld device under two
thousand dollars against those of a bigger and more expensive ultrasound machine.
thousand dollars against those of a bigger and more expensive ultrasound machine.
Ultrasound technology is frequently used to obtain information, usually at patients bedside.
The images obtained are used to guide procedure (i.e central line placement, epidural needle
guidance) or to make diagnosis (i.e abnormal placentation, presence of pneumothorax). Given
that the majority of this procedures and diagnosis are made at bedside, the ideal ultrasound
machine should be portable, lightweight, and within an acceptable price range. Our current
ultrasound machine (Sonosite - M turbo) has a price range from 15,000-20,000 dollars, not
including the different probes that are needed to obtain images at different depths in the
human body. Much of the cost is due to the ultrasound transducers, which have been
traditionally based on piezoelectric technology. Such probes work by passing current through
a piezoelectric crystal (typically quartz) that then vibrates rapidly and generates an
ultrasound pulse. Creating crystal arrays is difficult and often requires hand-manufacturing.
Furthermore, this technology is analog and requires downstream analog-to-digital processing
hardware. Together, these characteristics increase device costs and restrict the broader
dissemination of ultrasound technology.
Recently, the Butterfly iQ company created an ultrasound that is portable and at a price of
slightly under two thousand dollars it allows the physician to obtain images for diagnostic
and/or procedural guidance using a single probe. The company was able to significantly
reduced the cost and the need for additional probes by utilizing Capacitive micro-machined
ultrasound transducers (CMUTs). Essentially instead of relying on the use of specific
piezoelectric crystals (current ultrasound technology), they are using a micro-chip
technology to emit the vibrations that would be used to form an image. Butterfly Network has
developed a CMUT imaging device that has been designed to be compliant with all applicable
FDA safety regulations (see section II.C), while enabling increased portability and real-time
smartphone-based image review due to the integrated circuit design. The Butterfly device was
FDA-approved as of October 2017. The proposed study will compare the images acquired by the
Butterfly iQ and our current Sonosite M-turbo US.
The images obtained are used to guide procedure (i.e central line placement, epidural needle
guidance) or to make diagnosis (i.e abnormal placentation, presence of pneumothorax). Given
that the majority of this procedures and diagnosis are made at bedside, the ideal ultrasound
machine should be portable, lightweight, and within an acceptable price range. Our current
ultrasound machine (Sonosite - M turbo) has a price range from 15,000-20,000 dollars, not
including the different probes that are needed to obtain images at different depths in the
human body. Much of the cost is due to the ultrasound transducers, which have been
traditionally based on piezoelectric technology. Such probes work by passing current through
a piezoelectric crystal (typically quartz) that then vibrates rapidly and generates an
ultrasound pulse. Creating crystal arrays is difficult and often requires hand-manufacturing.
Furthermore, this technology is analog and requires downstream analog-to-digital processing
hardware. Together, these characteristics increase device costs and restrict the broader
dissemination of ultrasound technology.
Recently, the Butterfly iQ company created an ultrasound that is portable and at a price of
slightly under two thousand dollars it allows the physician to obtain images for diagnostic
and/or procedural guidance using a single probe. The company was able to significantly
reduced the cost and the need for additional probes by utilizing Capacitive micro-machined
ultrasound transducers (CMUTs). Essentially instead of relying on the use of specific
piezoelectric crystals (current ultrasound technology), they are using a micro-chip
technology to emit the vibrations that would be used to form an image. Butterfly Network has
developed a CMUT imaging device that has been designed to be compliant with all applicable
FDA safety regulations (see section II.C), while enabling increased portability and real-time
smartphone-based image review due to the integrated circuit design. The Butterfly device was
FDA-approved as of October 2017. The proposed study will compare the images acquired by the
Butterfly iQ and our current Sonosite M-turbo US.
Inclusion Criteria:
- Patients needing a routine obstetric scan or requesting a transverse abdominis block,
labor epidural or spinal for cesarean delivery.
Exclusion Criteria:
- Body Mass Index (BMI) > 45
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