This is a prospective, comparative, blinded, randomized study to prove the safety, efficacy and ease of use of the LifeFlow® device in pediatric patients presenting to an emergency department with concern for sepsis. This study will include 600 patients, 300 will receive the LifeFlow® device to deliver intravenous fluids while another 300 patients will receive the conventional push/pull method.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Use of rapid infuser to fluid resuscitate
Use of Push Pull syringe technique to fluid resuscitate
Phoenix Children's
Phoenix, Arizona, United States
Time To first bolus completion
Time frame: 20 Minutes
Time to third bolus completion
Time frame: 60 Minutes
Time to hospital admission
Time from presentation to the ER until admission to the hospital
Time frame: 24 hours
Nursing satisfaction
Likert scale of satisfaction with style of fluid administration used. From not satisfied to extremely satisfied.
Time frame: 1 day
Hospital Length of Stay
Time frame: Days
ICU days
Time frame: Days
Vasoactive medication use
Will measure whether vasoactive medications are used or not used
Time frame: 1 day
Morbidity and Mortality
rate of morbidity and mortality per 100 subjects in each arm
Time frame: 1 day
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