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

NCT03712189 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-08

Study results available
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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.

Conditions

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Todd P Chang, MD · Children's Hospital Los Angeles

  • Ara Festekjian, MD · Children's Hospital Los Angeles

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
1 Month
Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-10-02
Primary Completion
2019-05-31
Completion
2019-06-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03712189 on ClinicalTrials.gov