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

Not Applicable

Completed

• Conditions: Dehydration; Dehydration in Children
• Interventions: Device: LifeFlow

• Registration Number: NCT03712189
• Lead Sponsor: Children's Hospital Los Angeles

Brief Summary

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

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 Timeline

• Study Start: 2018-10-02
• Study First Submitted: 2018-10-11
• Study First Submitted QC: 2018-10-17
• Study First Posted: 2018-10-19
• Primary Completion: 2019-05-31
• Study Completion: 2019-06-30
• Results First Submitted: 2021-01-25
• Results First Submitted QC: 2021-02-16
• Results First Posted: 2021-02-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-04
• Last Update Posted: 2024-01-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Duration- Ultrasound Ordered to Completed	From ED (Emergency Department) arrival to discharge/admission, less than 12 hours	The primary outcome variable is the duration (minutes) of time from when the ultrasound was ordered to the completion time of the ultrasound.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Children's Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States