Novel Device for Rapid Fluid Administration

Yale University

Status: Completed

Conditions: Device Related Sepsis

Treatments: Device: Lifeflow; Device: Push/Pull; Device: Pressure Bag

Study type: Interventional

Funder types: Other

Identifiers

NCT03074682

1612018709

Details and patient eligibility

About

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.

Full 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.

Enrollment: 54 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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54 participants in 3 patient groups

Lifeflow

Experimental group

Description:

Participants in this arm will use the Lifeflow device to administer fluid in a simulation in a simulation setting.

Treatment:

Device: Lifeflow

Push/Pull

Active Comparator group

Description:

Participants in this arm will use the Push/Pull method to administer fluid in a simulation in a simulation setting.

Treatment:

Device: Push/Pull

Pressure Bag

Active Comparator group

Description:

Participants in this arm will use a Pressure Bag to administer fluid in a simulation in a simulation setting.

Treatment:

Device: Pressure Bag