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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Dehydration in Children, Dehydration

Intervention / Treatment
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* Device: LifeFlow


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Alaris Pump<br>Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full. | |
| Experimental: LifeFlow<br>Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full. | Device: LifeFlow<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | From ED (Emergency Department) arrival to discharge/admission, less than 12 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total IV Fluid (mL) | Total IV fluid administered before ultrasound | From ED arrival to discharge/admission, less than 12 hours | 
| Duration- Full Bladder | Fluid initiation and subjective sensation of full bladder | From ED arrival to discharge/admission, less than 12 hours |