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
|Condition or disease||Intervention/treatment||Phase|
|Dehydration in Children Dehydration||Device: LifeFlow||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|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|
No Intervention: Alaris Pump
Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full.
Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full.
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.
- 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.
- Total IV fluid (mL) [ Time Frame: From ED arrival to discharge/admission, less than 12 hours ]Total IV fluid administered before ultrasound
- Duration- Full bladder [ Time Frame: From ED arrival to discharge/admission, less than 12 hours ]Fluid initiation and subjective sensation of full bladder
- Duration- Nursing [ Time Frame: From ED arrival to discharge/admission, less than 12 hours ]Nursing time required to administer the fluids
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
|United States, California|
|Children's Hospital Los Angeles|
|Los Angeles, California, United States, 90026|
|Principal Investigator:||Todd P Chang, MD||Children's Hospital Los Angeles|
|Study Director:||Ara Festekjian, MD||Children's Hospital Los Angeles|