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.

Study Overview

• Status: Completed
• Conditions: Dehydration in Children; Dehydration
• Intervention / Treatment: Device: LifeFlow

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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90026
      • Children's Hospital Los Angeles

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 1 month to 18 years (Child, Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Children's Hospital Los Angeles
• Collaborators: 410 Medical; Atlanta Pediatric Device Consortium
• Investigators: Principal Investigator: Todd P Chang, MD, Children's Hospital Los Angeles; Study Director: Ara Festekjian, MD, Children's Hospital Los Angeles

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2018
• Primary Completion (Actual): May 31, 2019
• Study Completion (Actual): June 30, 2019

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 19, 2018

Study Record Updates

• Last Update Posted (Estimated): January 8, 2024
• Last Update Submitted That Met QC Criteria: January 4, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Water-Electrolyte Imbalance; Dehydration
• Other Study ID Numbers: CHLA-18-00188

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes