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Novel Device for Rapid Fluid Administration

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Yale University

Status

Completed

Conditions

Device Related Sepsis

Treatments

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

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

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

Trial documents
2

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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