The Utility of LifeFlow Rapid Fluid Infuser in Critical and Non-critical Pediatric Patients: a Mixed-method Pilot Study Protocol
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dehydration in Children
- Sponsor
- Children's Hospital Los Angeles
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Duration- Ultrasound Ordered to Completed
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
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.
Investigators
Todd P Chang, MD MAcM
Principal Investigator
Children's Hospital Los Angeles
Eligibility 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
Outcomes
Primary Outcomes
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
- Total IV Fluid (mL)(From ED arrival to discharge/admission, less than 12 hours)
- Duration- Full Bladder(From ED arrival to discharge/admission, less than 12 hours)