NCT07722065

Brief Summary

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).

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable surgery

Timeline
16mo left

Started Aug 2026

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 20, 2026

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 23, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

July 23, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

July 20, 2026

Last Update Submit

July 20, 2026

Conditions

Surgery

Outcome Measures

Primary Outcomes (1)

  • RASS

    The ability of a hand held cardiac ultrasound in detecting successful peripheral IV placement using the right atrial swirl sign (RASS) compared to a traditional ultrasound.

    Baseline

Secondary Outcomes (1)

  • Time

    Baseline

Study Arms (2)

Sonosite

ACTIVE COMPARATOR

Sonosite® ultrasound device with a linear probe.

Device: Sonosite

Lumify

EXPERIMENTAL

A novel, handheld ultrasound device with a cardiac phase array probe that is attached to a tablet.

Device: Lumify®

Interventions

SonositeDEVICE

A stand alone ultrasound machine with a linear probe.

Sonosite
Lumify®DEVICE

A novel, handheld ultrasound device with a cardiac phase array probe attached to a tablet.

Lumify

Eligibility Criteria

Age1 Year - 6 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • pediatric patients ranging in age from 1-6 years
  • presenting for surgery and requiring placement of an intravenous cannula.

You may not qualify if:

  • potential subjects that are fluid or sodium sensitive

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Study Officials

  • Alok Moharir, MD

    Nationwide Children's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 20, 2026

First Posted

July 23, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

July 23, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)