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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03712189
Other study ID # CHLA-18-00188
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date October 2, 2018
Est. completion date June 30, 2019

Study information

Verified date January 2024
Source Children's Hospital Los Angeles
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 30, 2019
Est. primary completion date May 31, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 1 Month to 18 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States Children's Hospital Los Angeles Los Angeles California

Sponsors (3)

Lead Sponsor Collaborator
Children's Hospital Los Angeles 410 Medical, Atlanta Pediatric Device Consortium

Country where clinical trial is conducted

United States, 

References & Publications (1)

Kline M, Crispino L, Bhatnagar A, Panchal RA, Auerbach M. A Randomized Single-Blinded Simulation-Based Trial of a Novel Method for Fluid Administration to a Septic Infant. Pediatr Emerg Care. 2021 Jun 1;37(6):e313-e318. doi: 10.1097/PEC.0000000000001583. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Duration- Ultrasound Ordered to Completed The primary outcome variable is the duration (minutes) of time from when the ultrasound was ordered to the completion time of the ultrasound. From ED (Emergency Department) arrival to discharge/admission, less than 12 hours
Secondary Total IV Fluid (mL) Total IV fluid administered before ultrasound From ED arrival to discharge/admission, less than 12 hours
Secondary Duration- Full Bladder Fluid initiation and subjective sensation of full bladder From ED arrival to discharge/admission, less than 12 hours
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