Comparing an Inexpensive Handheld Ultrasound Machine and a Large Mobile Ultrasound System

Ultrasonography Clinical Trial

Official title:

Ultrasound Image Quality Comparison Between an Inexpensive Handheld Ultrasound Machine and a Large Mobile Ultrasound System

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764111
• Other study ID #: 2000024151
• Status: Completed
• Start date: October 23, 2018
• Est. completion date: December 30, 2020

Study information

• Verified date: July 2021
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 30, 2020
• Est. primary completion date: November 11, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Ultrasonography

Intervention

Device:
• Large Mobile Ultrasound System
30 spine images, 15 Transverse abdominis muscle and 30 Obstetric images (i.e placenta, uterine blood flow, etc) images will be obtained using the large mobile ultrasound system.
• Handheld Ultrasound Machine
30 spine images, 15 Transverse abdominis muscle and 30 Obstetric images (i.e placenta, uterine blood flow, etc) images will be obtained using the handheld device.

Locations

Country	Name	City	State
United States	Yale University	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Yale University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Khuri-Yakub BT, Oralkan O. Capacitive micromachined ultrasonic transducers for medical imaging and therapy. J Micromech Microeng. 2011 May;21(5):54004-54014. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ultrasound image quality-resolution	Images will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.	Prior to start of active labor or before elective cesarean delivery
Primary	Ultrasound image quality-details	Images will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.	Prior to start of active labor or before elective cesarean delivery
Primary	Ultrasound image quality-total image quality	Images will be rated on a 10-point Likert-type scale; higher scores indicate better image quality.	Prior to start of active labor or before elective cesarean delivery