Handheld Ultrasound Device for Surgery
What You Need to Know Before You Apply
What is the purpose of this trial?
This a prospective study in pediatric patients undergoing surgery and requiring placement of an intravenous cannula. This will be a novel study to assess whether a handheld compatible cardiac ultrasound device (Lumify) can be used to quickly and reliably verify successful vascular cannulation in pediatric patients using the rapid atrial swirl sign (RASS) technique. As emerging technologies have made hand-held ultrasound devices more versatile, portable, and cheaper, it will be important to prove if they can be as accurate as traditional ultrasound devices for their intended focused point-of-care functions. If the handheld device is deemed efficacious, it will allow the use of a portable hand-held device rather than the more difficult to transport devices (Sonosite).
Who Is on the Research Team?
Alok Moharir, MD
Principal Investigator
Nationwide Children's Hospital
Are You a Good Fit for This Trial?
This trial is for children aged 1 to 6 years who are having surgery and need an IV line placed. Kids who have issues with fluid or salt balance cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Baseline imaging and assessment using handheld and traditional ultrasound devices
Procedure
Participants undergo surgery requiring intravenous cannulation, verified using ultrasound devices
Follow-up
Participants are monitored for safety and effectiveness after the procedure
What Are the Treatments Tested in This Trial?
Trial Overview
The study compares a handheld ultrasound device (Lumify) to a traditional one (Sonosite) to see if the portable device can quickly and accurately confirm that an IV has been correctly placed in young children during surgery.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
A novel, handheld ultrasound device with a cardiac phase array probe that is attached to a tablet.
Sonosite® ultrasound device with a linear probe.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alok Moharir
Lead Sponsor
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