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Handheld US Device to Verify Vascular Cannulation

NCT07722065 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2026-07-23

No results posted yet for this study

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).

Conditions

  • Surgery

Interventions

DEVICE

Sonosite

A stand alone ultrasound machine with a linear probe.

DEVICE

Lumify®

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

Sponsors & Collaborators

  • Alok Moharir

    lead OTHER

Principal Investigators

  • Alok Moharir, MD · Nationwide Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-31
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07722065 on ClinicalTrials.gov