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

The Utility of LifeFlow Rapid Fluid Infuser in Critical and Non-critical Pediatric Patients: a Mixed-method Pilot Study Protocol

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.

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

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

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.

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

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

Kline M, Crispino L, Bhatnagar A, Panchal RA, Auerbach M. A Randomized Single-Blinded Simulation-Based Trial of a Novel Method for Fluid Administration to a Septic Infant. Pediatr Emerg Care. 2021 Jun 1;37(6):e313-e318. doi: 10.1097/PEC.0000000000001583.