Handheld US Device to Verify Vascular Cannulation

Part of paid clinical trials in Columbus, Ohio.

Sponsor
Alok Moharir
Study ID
NCT07722065
Status
Enrolling By Invitation

Conditions

  • Surgery

Eligibility Criteria

Sex
ALL
Age
1 Year - 6 Years
Healthy Volunteers
Not accepted

Interventions

  • Sonosite — DEVICE
    A stand alone ultrasound machine with a linear probe.
  • Lumify® — DEVICE
    A novel, handheld ultrasound device with a cardiac phase array probe attached to a tablet.

Study Details

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).

Key Dates

First listed
Jul 23, 2026
Start date
Aug 31, 2026
Status verified
Jul 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
100 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Sonosite
    Sonosite® ultrasound device with a linear probe.
  • Experimental: Lumify
    A novel, handheld ultrasound device with a cardiac phase array probe that is attached to a tablet.

Primary Outcome Measure

RASS [ Time Frame: Baseline ]

Locations (1)

FacilityCityStateZIPSite coordinators
Nationwide Children's HospitalColumbusOhio43205-

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