NCT03074682

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
54

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2017

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2017

Completed
27 days until next milestone

First Submitted

Initial submission to the registry

February 28, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 9, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2017

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

January 31, 2019

Completed
Last Updated

January 31, 2019

Status Verified

January 1, 2019

Enrollment Period

4 months

First QC Date

February 28, 2017

Results QC Date

November 16, 2018

Last Update Submit

January 29, 2019

Conditions

Device Related Sepsis

Keywords

Resuscitation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Time to Complete Fluid Administration

    Up to 20 minutes

  • NASA Task Load Index (TLX)

    15 minutes

Other Outcomes (1)

  • Post Intervention Survey

    15 minutes

Study Arms (3)

Lifeflow

EXPERIMENTAL

Participants in this arm will use the Lifeflow device to administer fluid in a simulation in a simulation setting.

Device: Lifeflow

Push/Pull

ACTIVE COMPARATOR

Participants in this arm will use the Push/Pull method to administer fluid in a simulation in a simulation setting.

Device: Push/Pull

Pressure Bag

ACTIVE COMPARATOR

Participants in this arm will use a Pressure Bag to administer fluid in a simulation in a simulation setting.

Device: Pressure Bag

Interventions

LifeflowDEVICE

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.

Lifeflow
Push/PullDEVICE

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
Pressure BagDEVICE

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

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Departments of Pediatrics and Emergency Medicine, Yale University

New Haven, Connecticut, 06511, United States

Location

Related Publications (1)

  • 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.

    PMID: 30106868BACKGROUND

MeSH Terms

Interventions

Double-Balloon Enteroscopy

Intervention Hierarchy (Ancestors)

Balloon EnteroscopyEndoscopy, GastrointestinalEndoscopy, Digestive SystemDiagnostic Techniques, Digestive SystemDiagnostic Techniques and ProceduresDiagnosisEndoscopyDiagnostic Techniques, SurgicalDigestive System Surgical ProceduresSurgical Procedures, OperativeMinimally Invasive Surgical Procedures

Results Point of Contact

Title
Dr. Marc Auerbach
Organization
Yale University
marc.auerbach@yale.edu
203-688-3333

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2017

First Posted

March 9, 2017

Study Start

February 1, 2017

Primary Completion

June 15, 2017

Study Completion

June 15, 2017

Last Updated

January 31, 2019

Results First Posted

January 31, 2019

Record last verified: 2019-01

Locations

US(1)