Trial Outcomes & Findings for LifeFlow Fluid Study- Non- Critical Pediatric Patients Having a Trans Abdominal Ultrasound (NCT NCT03712189)

NCT ID: NCT03712189

Last Updated: 2024-01-08

Results Overview

The primary outcome variable is the duration (minutes) of time from when the ultrasound was ordered to the completion time of the ultrasound.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 30 participants
• Primary outcome timeframe: From ED (Emergency Department) arrival to discharge/admission, less than 12 hours
• Results posted on: 2024-01-08

Participant Flow

Participant milestones

Measure	Alaris Pump Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full.	LifeFlow Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full. 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.
Overall Study STARTED	15	15
Overall Study COMPLETED	15	15
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Alaris Pump n=15 Participants Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full.	LifeFlow n=15 Participants Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full. 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.	Total n=30 Participants Total of all reporting groups
Age, Categorical <=18 years	15 Participants n=15 Participants	15 Participants n=15 Participants	30 Participants n=30 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Age, Continuous	13.6 years STANDARD_DEVIATION 2.9 • n=15 Participants	13.9 years STANDARD_DEVIATION 3.5 • n=15 Participants	13.8 years STANDARD_DEVIATION 3.1 • n=30 Participants
Sex: Female, Male Female	15 Participants n=15 Participants	15 Participants n=15 Participants	30 Participants n=30 Participants
Sex: Female, Male Male	0 Participants n=15 Participants	0 Participants n=15 Participants	0 Participants n=30 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	15 participants n=15 Participants	15 participants n=15 Participants	30 participants n=30 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Alaris Pump n=15 Participants Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full.	LifeFlow n=15 Participants Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full. 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.
Duration- Ultrasound Ordered to Completed	154.4 minutes Standard Deviation 53.2	114.8 minutes Standard Deviation 31.9

SECONDARY outcome

Timeframe: From ED arrival to discharge/admission, less than 12 hours

Total IV fluid administered before ultrasound

Outcome measures

Measure	Alaris Pump n=15 Participants Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full.	LifeFlow n=15 Participants Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full. 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.
Total IV Fluid (mL)	1612.9 mL Standard Deviation 654.4	1482.7 mL Standard Deviation 676.3

SECONDARY outcome

Timeframe: From ED arrival to discharge/admission, less than 12 hours

Fluid initiation and subjective sensation of full bladder

Outcome measures

Measure	Alaris Pump n=15 Participants Participants will receive IV fluids delivered by the Alaris IV Pump (standard of care) until their bladder is full.	LifeFlow n=15 Participants Participants will receive IV fluids delivered by the LifeFlow Fluid Device until their bladder is full. 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.
Duration- Full Bladder	61.9 minutes Standard Deviation 43.6	26.9 minutes Standard Deviation 18.9

Adverse Events

Alaris Pump

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

LifeFlow

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr Todd P Chang

Children's Hospital Los Angeles

Phone: 13233612109

Email: tochang@chla.usc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place