The Utility of LifeFlow Rapid Fluid Infuser in Critical and Non-critical Pediatric Patients: a Mixed-method Pilot Study Protocol
Phase: NA
Conditions: Dehydration in Children, Dehydration
Sponsor: Children's Hospital Los Angeles

 
 
 
 
The Utility of LifeFlow rapid infuser in 
critical and non-critical pediatric 
patients: a mixed-method pilot study 
protocol (CHLA) – Non-Critical Patients 
receiving Pelvic Ultrasounds 
 
IRB Approval Date: May 22, 2018 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
 
A 
Objectives/Purpose 
To describe fluid infusion experiences in the clinical setting for rapid fluid delivery 
among non-critical pediatric patients. 
 
 
B 
Hypotheses 
The null hypothesis is that both groups of fluid delivery will have no difference in 
duration in ultrasound completion.  
 
C 
Background 
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.  
 
In simulation studies, the LifeFlow® device compared to the push-pull techniques 
was able to deliver 1L of fluid in an average of 5.3 minute compared to 12.1 
minutes, respectively, which fulfills the Davis et al. recommendation of 20mL/kg 
fluid bolus within 5 minutes (for a 50kg child).3 
 
D 
Significance of the research 
To describe fluid infusion experiences in the clinical setting for rapid fluid delivery 
among critical pediatric patients. 
 
E 
Study Design 
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.  
 
F 
Research Plan 
 
1 
Subjects  
a 
Number of Subjects  
This is a preliminary pilot study to establish outcome values and no 
formal sample size is calculated.  We will enroll a minimum of 30 
subjects, 15 in each arm. 
b 
Inclusion criteria 
Inclusion criteria apply to patients older than 1 month and <18 years 
requiring IV crystalloid bolus fluids before a pelvic ultrasound in the ED at 
CHLA. 
c 
Exclusion criteria 
Exclusion criteria apply to subjects with known cardiac insufficiency or 
significant cardiac surgery, hepatic insufficiency, or renal insufficiency, or 
any known fluid overload states (e.g. ascites, pulmonary edema).  
Additional exclusion criteria include subjects on diuretic or antihypertensive 
therapy, and subjects with a positive pregnancy test. 
 
d 
Recruitment Methods  
Subjects will be verbally solicited in the Emergency Department 
e 
Informed Consent Process 
Informed consent will be conducted in a private room by a member of the 
research team. Assent will be obtained if necessary.  

 
 
f 
Vulnerable Subjects  
This research will be conducted on children and non-English speaking 
populations. 
g 
Compensation to Subjects  
No financial compensation 
h 
Treatment for Research-Related Injuries  
This research study is funded by Atlanta Pediatric Device Consortium. 
Participants and their families are not responsible for any costs involved 
with recording data from the medical records for this study. 
2 
Research Methods and Procedures  
a 
General description of methods and procedures 
- 
Surveillance of board for pelvic ultrasound orders on female patients 
- 
Approach care team (attending and nurse) and explain study, 
confirm that they are okay with patient participating. Explain that if 
the participant is assigned to the LifeFlow group, the nurse must be 
present to administer fluids with LifeFlow device. 
- 
Approach family and verify inclusion/exclusion criteria. If family is 
eligible, begin informed consent process. 
- 
Use randomization scheme to assign to group, tell care team and 
family which group the patient is assigned to 
- 
Record the participant’s age, weight, BMI, clinical dehydration score, 
suspected diagnosis. 
3 
Summary of Visits and Procedures 
a 
Procedures Just for Research Purposes 
 
Randomization into LifeFlow or Alaris pump group 
b 
How Participation Differs from Standard-of-Care 
This study includes procedures that are also a part of the standard 
treatment the patient’s condition. The transabdominal pelvic ultrasound is 
being done as part of standard of care and it is also standard of care to fill 
the patient’s bladder with IV fluids before the ultrasound 
c 
Study Duration 
 
The study will last the duration of time it takes to fill the patient’s bladder 
4 
Data Analysis Plan, Statistical Tests, and Sample Size Rationale  
This is a preliminary pilot study to establish outcome values and no formal 
sample size is calculated.  We will enroll a minimum of 30 subjects, 15 in each 
arm.  Univariate statistics will examine associations between the predictor 
variables and the outcome variable; an ANCOVA will be used to determine 
differences between the two fluid delivery modalities and the primary outcome. 
G 
Risks and Benefits 
 
1 
Potential Risks due to Study participation  
There is the potential of accidental release of confidential information. 
Participants may experience a cold sensation with fluid administration by any 
device, including the LifeFlow® or an IV pump such as the Alaris ® pump. 
Participants may also experience some discomfort around the IV site. 
2 
Minimizing Risks  
All clinical staff will monitor for signs of IV discomfort.  
 
3 
Potential Benefits  
A possible benefit from this study is that patients’ ultrasound may be completed 
more quickly in the LifeFlow group because fluid is delivered faster. In addition, 
information from this study will help doctors understand fluid infusion experiences in 
the Emergency Department and Pediatric Intensive Care Unit. 

 
 
 
H 
Procedures to Maintain Privacy and Confidentiality 
The data collected as part of this study will be de-identified and coded before being 
entered into the REDCap Database. All identifiable data will be kept in locked cabinets 
or in password protected electronic files only accessible by the research team.