NCT03074682 - Novel Device for Rapid Fluid Administration | Crick

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Enrollment

54

Conditions

Device Related Sepsis

Interventions

LifeflowDEVICE

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.

Push/PullDEVICE

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.

Pressure BagDEVICE

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.

Eligibility

Sex: ALLHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Departments of Pediatrics and Emergency Medicine, Yale University

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

Successful Administration of 60 mL/kg

Participants will be timed to determine if they are able to administer 60 mL/kg of fluid within a 20 minute timeframe. This outcome will be measured as a dichotomous 'yes' or 'no' as to whether the task was completed successfully. The initial registered primary outcome was changed from 60 cc/kg in 15 minutes to its current format before the study began.

Time frame: 20 minutes

Secondary Outcomes

Time to Complete Fluid Administration

Participants will be timed to determine if they are able to administer 60 mL/kg of fluid within a 20 minute timeframe. The time in which they complete the task will be captured in minutes. The initial registered primary outcome was changed from 60 cc/kg in 15 minutes to its current format before the study began.

Time frame: Up to 20 minutes

NASA Task Load Index (TLX)

The NASA Task Load Index (TLX) is a series of measures that capture workload. Each scale employs a visual analog scale that measures each of the domains. The domains are Mental Domain, Physical Demand, Temporal Demand, Performance, Effort and Frustration Level. Each scale domain and the Composite has a range from 0 to 100 with 100 being the highest indicator of workload.

Time frame: 15 minutes