NCT03074682|CompletedResultsFDA Device
Novel Device for Rapid Fluid Administration
Fluid Administration With LifeFlow vs Push/Pull
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Sponsor study identifier
interventional
54
1 country
1
Study Start
February 1, 2017
Actual (reported)Primary Completion
June 15, 2017
Actual (reported)Study Completion
June 15, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 15, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
February 1, 2017
Actual (reported)February 28, 2017
Actual (reported)March 9, 2017
Actual (reported)June 15, 2017
Actual (reported)June 15, 2017
Actual (reported)January 31, 2019
Actual (reported)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
Time to Complete Fluid Administration
Up to 20 minutes
NASA Task Load Index (TLX)
15 minutes
Post Intervention Survey
15 minutes
Participants in this arm will use the Lifeflow device to administer fluid in a simulation in a simulation setting.
Participants in this arm will use the Push/Pull method to administer fluid in a simulation in a simulation setting.
Participants in this arm will use a Pressure Bag to administer fluid in a simulation in a simulation setting.
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.
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.
Departments of Pediatrics and Emergency Medicine, Yale University
New Haven, Connecticut, 06511, United States
Kline M, Crispino L, Bhatnagar A, Panchal RA, Auerbach M. A Randomized Single-Blinded Simulation-Based Trial of a Novel Method for Fluid Administration to a Septic Infant. Pediatr Emerg Care. 2021 Jun 1;37(6):e313-e318. doi: 10.1097/PEC.0000000000001583.
54 participants (actual enrollment reported by the registry).
First Submitted
February 28, 2017
First Posted
March 9, 2017
Study Start
February 1, 2017
Actual (reported)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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Primary Completion
June 15, 2017
Actual (reported)Study Completion
June 15, 2017
Actual (reported)Last Updated
January 31, 2019
Results First Posted
January 31, 2019
Record last verified: 2019-01
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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