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Enrolling by invitation NCT07722065

Handheld US Device to Verify Vascular Cannulation

No phase Interventional Surgery

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sonosite, Lumify®.
Who it may be relevant to
Registry conditions: Surgery. Basic parameters: 1 year — 6 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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).

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.

Primary outcome measures

  • RASS [Time frame: Baseline]
Secondary outcome measures (1)
  • Time [Time frame: Baseline]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Single group
Masking
Double blind
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Nationwide Children's Hospital — Columbus

Identifiers

NCT: NCT07722065 · STUDY00001776

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗