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
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Oct 2018
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 2, 2018
CompletedFirst Submitted
Initial submission to the registry
October 11, 2018
CompletedFirst Posted
Study publicly available on registry
October 19, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2019
CompletedResults Posted
Study results publicly available
February 21, 2021
CompletedJanuary 8, 2024
January 1, 2024
8 months
October 11, 2018
January 25, 2021
January 4, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Total IV Fluid (mL)
From ED arrival to discharge/admission, less than 12 hours
Duration- Full Bladder
From ED arrival to discharge/admission, less than 12 hours
Study Arms (2)
Alaris Pump
NO INTERVENTIONParticipants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full.
LifeFlow
EXPERIMENTALParticipants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Female patients older than 1 month and less than 18 years
- Patients require IV crystalloid bolus fluids before a pelvic ultrasound
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Children's Hospital Los Angeleslead
- 410 Medicalcollaborator
- Atlanta Pediatric Device Consortiumcollaborator
Study Sites (1)
Children's Hospital Los Angeles
Los Angeles, California, 90026, United States
Related Publications (1)
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.
PMID: 30106868BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr Todd P Chang
- Organization
- Children's Hospital Los Angeles
Study Officials
- PRINCIPAL INVESTIGATOR
Todd P Chang, MD
Children's Hospital Los Angeles
- STUDY DIRECTOR
Ara Festekjian, MD
Children's Hospital Los Angeles
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 11, 2018
First Posted
October 19, 2018
Study Start
October 2, 2018
Primary Completion
May 31, 2019
Study Completion
June 30, 2019
Last Updated
January 8, 2024
Results First Posted
February 21, 2021
Record last verified: 2024-01
Data Sharing
- IPD Sharing
- Will not share