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

Dehydration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03712189
• Other study ID #: CHLA-18-00188
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Dehydration
• Dehydration in Children

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