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

NCT ID: NCT03764111

Last Updated: 2021-07-22

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 60 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-10-23
• Study Completion Date: 2020-12-30

Brief 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.

Detailed 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.

Conditions

Ultrasonography

Study Design

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

Study Groups

large mobile ultrasound system

the ultrasound transducer is based on piezoelectric technology.

Large Mobile Ultrasound System

Intervention Type: DEVICE

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

The handheld device utilizes Capacitive micro-machined ultrasound transducers (CMUTs) instead of piezoelectric technology

Handheld Ultrasound Machine

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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.

Intervention Type: DEVICE

Other Intervention Names

Sonosite - M turbo; Butterfly iQ device

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Antonio Gonzalez, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University

New Haven, Connecticut, United States

Countries

United States

References

Khuri-Yakub BT, Oralkan O. Capacitive micromachined ultrasonic transducers for medical imaging and therapy. J Micromech Microeng. 2011 May;21(5):54004-54014. doi: 10.1088/0960-1317/21/5/054004.

Reference Type: BACKGROUND

PMID: 21860542 (View on PubMed)

Other Identifiers

2000024151

Identifier Type: -

Identifier Source: org_study_id