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Completed

NCT Number: NCT03074682

Novel Device for Rapid Fluid Administration

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.

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Key information

Conditions

Device Related Sepsis

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Departments of Pediatrics and Emergency Medicine, Yale University

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lifeflow

Device

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/Pull

Device

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 Bag

Device

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.

Primary outcomes

  1. Successful Administration of 60 mL/kg

    Time frame: 20 minutes

    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.

Secondary outcomes

  1. Time to Complete Fluid Administration

    Time frame: Up to 20 minutes

    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.

  2. NASA Task Load Index (TLX)

    Time frame: 15 minutes

    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.

Other outcomes

  1. Post Intervention Survey

    Time frame: 15 minutes

    A qualitative questionnaire will be administered to participants following the simulation. Questions include information about experience with various methods and other feedback relevant to evaluation. This outcome was included in the registration is actually captured by the NASA Task Load Index (TLX) that was reported.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Official study title

Fluid Administration With LifeFlow vs Push/Pull

Important dates

Study start
2017
Primary completion
2017
Study completion
2017
First posted
Mar 9, 2017
Registry last updated
Jan 31, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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