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Clinical Trials/NCT03074682
NCT03074682
Completed
N/A

Fluid Administration With LifeFlow vs Push/Pull

Yale University1 site in 1 country54 target enrollmentFebruary 1, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Device Related Sepsis
Sponsor
Yale University
Enrollment
54
Locations
1
Primary Endpoint
Successful Administration of 60 mL/kg
Status
Completed
Last Updated
7 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 1, 2017
End Date
June 15, 2017
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Time to Complete Fluid Administration(Up to 20 minutes)
  • NASA Task Load Index (TLX)(15 minutes)

Study Sites (1)

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