Novel Device for Rapid Fluid Administration

Not Applicable

Completed

• Conditions: Device Related Sepsis
• Interventions: Device: Pressure Bag; Device: Lifeflow; Device: Push/Pull

• Registration Number: NCT03074682
• Lead Sponsor: Yale University

Brief Summary

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

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 Timeline

• Study Start: 2017-02-01
• Study First Submitted: 2017-02-28
• Study First Submitted QC: 2017-03-03
• Study First Posted: 2017-03-09
• Primary Completion: 2017-06-15
• Study Completion: 2017-06-15
• Results First Submitted: 2018-11-16
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-29
• Last Update Submitted: 2019-01-29
• Results First Posted: 2019-01-31
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Pediatric emergency medicine or pediatric intensive care unit nurses, pediatric residents, medics and attendings.

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Exclusion Criteria

• Inability to operate equipment due to illness or physical impairment.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pressure Bag	Pressure Bag	Participants in this arm will use a Pressure Bag to administer fluid in a simulation in a simulation setting.
Lifeflow	Lifeflow	Participants in this arm will use the Lifeflow device to administer fluid in a simulation in a simulation setting.
Push/Pull	Push/Pull	Participants in this arm will use the Push/Pull method to administer fluid in a simulation in a simulation setting.

Primary Outcome Measures

Name	Time	Method
Successful Administration of 60 mL/kg	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 Outcome Measures

Name	Time	Method
Time to Complete Fluid Administration	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.
NASA Task Load Index (TLX)	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.

Trial Locations

Locations (1)

Departments of Pediatrics and Emergency Medicine, Yale University; 🇺🇸 New Haven, Connecticut, United States