Handheld Ultrasound Device for Surgery

Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: Alok Moharir
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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?

AM

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

I am between 1 and 6 years old.
I am having surgery and need an IV placed.

Exclusion Criteria

Potential subjects that are fluid or sodium sensitive

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline Assessment

Baseline imaging and assessment using handheld and traditional ultrasound devices

1 day
1 visit (in-person)

Procedure

Participants undergo surgery requiring intravenous cannulation, verified using ultrasound devices

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

1-2 weeks

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

Group I: LumifyExperimental Treatment1 Intervention
Group II: SonositeActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Alok Moharir

Lead Sponsor

Trials
3
Recruited
250+