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

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ClinicalTrials.gov Identifier: NCT03712189
Recruitment Status : Completed
First Posted : October 19, 2018
Last Update Posted : July 24, 2019
Sponsor:
Collaborators:
410 Medical
Atlanta Pediatric Device Consortium
Information provided by (Responsible Party):
Children's Hospital Los Angeles

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.

Condition or disease Intervention/treatment Phase
Dehydration in Children Dehydration Device: LifeFlow Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: The Utility of LifeFlow Rapid Fluid Infuser in Critical and Non-critical Pediatric Patients: a Mixed-method Pilot Study Protocol
Actual Study Start Date : October 2, 2018
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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




Primary Outcome Measures :
  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 Outcome Measures :
  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

  3. Duration- Nursing [ Time Frame: From ED arrival to discharge/admission, less than 12 hours ]
    Nursing time required to administer the fluids



Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03712189


Locations
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United States, California
Children's Hospital Los Angeles
Los Angeles, California, United States, 90026
Sponsors and Collaborators
Children's Hospital Los Angeles
410 Medical
Atlanta Pediatric Device Consortium
Investigators
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Principal Investigator: Todd P Chang, MD Children's Hospital Los Angeles
Study Director: Ara Festekjian, MD Children's Hospital Los Angeles
  Study Documents (Full-Text)

Documents provided by Children's Hospital Los Angeles:

Publications:
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Responsible Party: Children's Hospital Los Angeles
ClinicalTrials.gov Identifier: NCT03712189     History of Changes
Other Study ID Numbers: CHLA-18-00188
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: July 24, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Additional relevant MeSH terms:
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Dehydration
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes