N/A N=54 Randomized Single-blind Other

Novel Device for Rapid Fluid Administration

Device Related Sepsis

Bottom Line

View on ClinicalTrials.gov: NCT03074682 ↗

Enrolled (actual)

Serious AEs

—

Results posted

Jan 2019

Primary outcome: Primary: Successful Administration of 60 mL/kg — 14; 18; 16 Participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Lifeflow (Device); Push/Pull (Device); Pressure Bag (Device)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Yale University
Primary completion: Jun 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Successful Administration of 60 mL/kg	14; 18; 16	—
SECONDARY Time to Complete Fluid Administration	718.9; 519.4; 376.5	—
SECONDARY NASA Task Load Index (TLX)	42.50; 40.42; 30.00; 60.00; 57.50; 37.50	—

Summary

The aim of the study is to determine if a new device is more effective in fluid administration than devices currently used when resuscitating pediatric patients in septic shock. This study will take place in a simulation lab setting and will not include the use of patients.

Eligibility Criteria

Inclusion Criteria

Pediatric emergency medicine or pediatric intensive care unit nurses, pediatric residents, medics and attendings.

Exclusion Criteria

Inability to operate equipment due to illness or physical impairment.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03074682). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.