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Completed

NCT Number: NCT03712189

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

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.

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Key information

Conditions

Dehydration in Children Dehydration Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Water-Electrolyte Imbalance

Age range

1 month–18 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles

Los Angeles, California, 90026, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lifeflow

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.

Primary outcomes

  1. Duration- Ultrasound Ordered to Completed

    Time frame: From ED (Emergency Department) arrival to discharge/admission, less than 12 hours

    The primary outcome variable is the duration (minutes) of time from when the ultrasound was ordered to the completion time of the ultrasound.

Secondary outcomes

  1. Total IV Fluid (mL)

    Time frame: From ED arrival to discharge/admission, less than 12 hours

    Total IV fluid administered before ultrasound

  2. Duration- Full Bladder

    Time frame: From ED arrival to discharge/admission, less than 12 hours

    Fluid initiation and subjective sensation of full bladder

Sponsors and collaborators

Lead sponsor

Children's Hospital Los Angeles

Other

Collaborators

  • 410 Medical
  • Atlanta Pediatric Device Consortium

Registry information

Official study title

The Utility of LifeFlow Rapid Fluid Infuser in Critical and Non-critical Pediatric Patients: a Mixed-method Pilot Study Protocol

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Oct 19, 2018
Registry last updated
Jan 8, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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