Clinical trial NCT03764111: Comparing an Inexpensive Handheld Ultrasound Machine and a Large Mobile Ultrasound System
Official title: Ultrasound Image Quality Comparison Between an Inexpensive Handheld Ultrasound Machine and a Large Mobile Ultrasound System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Ultrasonography
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2018-12-04
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients between the ages of 18 and 45 presenting for cesarean delivery requesting a transverse abdominis block, epidural, or in need of an obstetric US.

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.

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

Primary outcomes:
measure: Ultrasound image quality-resolution
timeFrame: Prior to start of active labor or before elective cesarean delivery
measure: Ultrasound image quality-details
timeFrame: Prior to start of active labor or before elective cesarean delivery
measure: Ultrasound image quality-total image quality
timeFrame: Prior to start of active labor or before elective cesarean delivery
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Antonio Gonzalez, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.