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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-02

Study Completion Date

2019-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Monitoring Patient Cerebro-Spinal Fluid Drainage With an Ultrasonic Flow Sensor

NCT00652197

Hydrocephalus

COMPLETED

Ultrasound Assisted Lumbar Puncture in the Neonate

NCT02918149

Lumbar Puncture

UNKNOWN NA

Ultrasound Confirmation of Endotracheal Tube Location Using a Saline Filled Cuff

NCT02131974

Pediatric Endotracheal Intubation (no Specific Condition)

COMPLETED

Point of Care UltraSound (POCUS) Use for Intravenous Catheter Placement During Pediatric Interfacility Transport

NCT04875988

Intravenous Access

UNKNOWN NA

Hyperhydration in Children With Shiga Toxin-Producing E. Coli Infection

NCT05219110

Shiga Toxin-Producing Escherichia Coli (E. Coli) Infection Hemolytic-Uremic Syndrome

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Dehydration in Children Dehydration

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Alaris Pump

Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full.

Group Type NO_INTERVENTION

No interventions assigned to this group

LifeFlow

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

Group Type EXPERIMENTAL

LifeFlow

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes