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

Children's Hospital Los Angeles

Status: Completed

Conditions: Dehydration; Dehydration in Children

Treatments: Device: LifeFlow

Study type: Interventional

Funder types: Other

Identifiers

NCT03712189

CHLA-18-00188

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: Female

Ages: 1 month to 18 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Alaris Pump

No Intervention group

Description:

Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full.

LifeFlow

Experimental group

Description:

Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full.

Treatment:

Device: LifeFlow