LifeFlow Fluid Study- Non- Critical Pediatric Patients Having a Trans Abdominal Ultrasound

Children's Hospital Los Angeles30 enrolled

Overview

This is an unblinded, randomized control study examining two fluid delivery modalities for non-critical female patients with a planned transabdominal pelvic ultrasound requiring intravenous fluid boluses.

Subjects be identified during their clinical course in the ED and will be randomized to either the LifeFlow® fluid delivery or an IV fluid bolus through the Alaris® pump (standard of care). IV fluids will be provided until the subject notes the sensation of a full bladder, at which point, the standard of care clinical practice is to perform the ultrasound. The transabdominal pelvic ultrasound requires a full bladder for optimal visualization of the ovaries, adnexa, and uterus, and is the only alternative to a transvaginal pelvic ultrasound for virginal young women. All other clinical care is per standard of care. The only research component is the randomization and data collection.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Dehydration in Children Dehydration

Interventions

LifeFlowDEVICE

The LifeFlow® is a hand-operated rapid infuser designed to administer fluids to patients by a single user, for clinical situations in which a large volume or rapid infusion of fluid or colloid is required. The device delivers fluid in 10mL increments with each complete handle compression, which refills during release, automating a push-pull mechanism. The syringe then automatically refills with handle release.

Eligibility

Sex: FEMALEMin age: 1 MonthMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Female patients older than 1 month and less than 18 years * Patients require IV crystalloid bolus fluids before a pelvic ultrasound Exclusion Criteria: * Known cardiac insufficiency or significant cardiac surgery * Hepatic insufficiency * Renal insufficiency * Any known fluid overload states (ascites, pulmonary edema) * On any diuretic or antihypertensive therapy * Known pregnancy

Locations (1)

Children's Hospital Los Angeles

Los Angeles, California, United States

Outcomes

Primary Outcomes

Duration- Ultrasound Ordered to Completed

The primary outcome variable is the duration (minutes) of time from when the ultrasound was ordered to the completion time of the ultrasound.

Time frame: From ED (Emergency Department) arrival to discharge/admission, less than 12 hours

Secondary Outcomes

Total IV Fluid (mL)

Total IV fluid administered before ultrasound

Time frame: From ED arrival to discharge/admission, less than 12 hours

Duration- Full Bladder

Fluid initiation and subjective sensation of full bladder

Time frame: From ED arrival to discharge/admission, less than 12 hours

Data from ClinicalTrials.gov

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