NCT03074682

Novel Device for Rapid Fluid Administration

Fluid Administration With LifeFlow vs Push/Pull

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Accepted

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.

Detailed description

In this study, participants will be randomized to one of three devices in a Pediatric Intensive Care Unit simulation setting. Each participant will be provided the device, a 1L NS bag, tubing and a 22g IV. In each scenario, the objective will be to administer 3 20cc/kg boluses within a 15 minute period to the simulated patient.

Conditions

• Device Related Sepsis

Interventions

Type	Name	Description
DEVICE	Lifeflow	Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid.
DEVICE	Push/Pull	Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid.
DEVICE	Pressure Bag	Following a 5-minute training video where instructions on device are presented to participants, participants are given the device, a 1L NS bag, tubing and a 22g IV. Prior to beginning the simulation, they will demonstrate ability to set up the device and fill an empty container with fluid.

Timeline

• Start date: 2017-02-01
• Primary completion: 2017-06-15
• Completion: 2017-06-15
• First posted: 2017-03-09
• Last updated: 2019-01-31
• Results posted: 2019-01-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study