Novel Device for Rapid Fluid Administration

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fluid Administration With LifeFlow vs Push/Pull

Conditions
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Device Related Sepsis

Intervention / Treatment
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* Device: Lifeflow
* Device: Push/Pull
* Device: Pressure Bag


Participation Criteria
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Eligibility Criteria
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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.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifeflow<br>Participants in this arm will use the Lifeflow device to administer fluid in a simulation in a simulation setting. | Device: Lifeflow<br>* 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.<br>|
| Active Comparator: Push/Pull<br>Participants in this arm will use the Push/Pull method to administer fluid in a simulation in a simulation setting. | Device: Push/Pull<br>* 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.<br>|
| Active Comparator: Pressure Bag<br>Participants in this arm will use a Pressure Bag to administer fluid in a simulation in a simulation setting. | Device: Pressure Bag<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 20 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 15 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Resuscitation