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

C

Children's Hospital Los Angeles

Status

Completed

Conditions

Dehydration
Dehydration in Children

Treatments

Device: LifeFlow

Study type

Interventional

Funder types

Other

Identifiers

NCT03712189
CHLA-18-00188

Details and patient eligibility

About

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.

Full 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.

Enrollment

30 patients

Sex

Female

Ages

1 month to 18 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Health Services Research

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

30 participants in 2 patient groups

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

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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