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OpenTrials
Enrolling by Invitation

NCT Number: NCT07722065

Handheld US Device to Verify Vascular Cannulation

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).

Enrolling by Invitation

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Key information

Conditions

Age range

1 year–6 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • potential subjects that are fluid or sodium sensitive

Treatment and study plan

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.

Primary outcomes

  1. RASS

    Time frame: Baseline

    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.

Secondary outcomes

  1. Time

    Time frame: Baseline

    The amount of time required to obtain the necessary imaging between the two devices.

Sponsors and collaborators

Lead sponsor

Alok Moharir

Other

Registry information

Official study title

The Use of a Handheld Cardiac Ultrasound Device to Verify Successful Peripheral Vascular Cannulation in Pediatric Patients.

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jul 23, 2026
Registry last updated
Jul 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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