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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lifeflow | Experimental | Participants in this arm will use the Lifeflow device to administer fluid in a simulation in a simulation setting. |
|
| Push/Pull | Active Comparator | Participants in this arm will use the Push/Pull method to administer fluid in a simulation in a simulation setting. |
|
| Pressure Bag | Active Comparator | Participants in this arm will use a Pressure Bag to administer fluid in a simulation in a simulation setting. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lifeflow | Device | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post Intervention Survey | A qualitative questionnaire will be administered to participants following the simulation. Questions include information about experience with various methods and other feedback relevant to evaluation. This outcome was included in the registration is actually captured by the NASA Task Load Index (TLX) that was reported. | 15 minutes |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Departments of Pediatrics and Emergency Medicine, Yale University | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30106868 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Pressure Bag | Participants in this arm will use a Pressure Bag to administer fluid in a simulation in a simulation setting. Pressure Bag: 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. |
| FG001 | Push/Pull | Participants in this arm will use the Push/Pull method to administer fluid in a simulation in a simulation setting. Push/Pull: 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. |
| FG002 | Lifeflow | Participants in this arm will use the Lifeflow device to administer fluid in a simulation in a simulation setting. Lifeflow: 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Pressure Bag | Participants in this arm will use a Pressure Bag to administer fluid in a simulation in a simulation setting. Pressure Bag: 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | 20 minutes |
|
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This study was conducted using patient simulation and looked at fluid administration across different techniques. The participants in the study were not at risk for adverse events and this information was not collected.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Pressure Bag | Participants in this arm will use a Pressure Bag to administer fluid in a simulation in a simulation setting. Pressure Bag: 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Marc Auerbach | Yale University | 203-688-3333 | marc.auerbach@yale.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Dec 21, 2016 | Nov 16, 2018 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 21, 2016 | Nov 19, 2018 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D058582 | Double-Balloon Enteroscopy |
| ID | Term |
|---|---|
| D000071087 | Balloon Enteroscopy |
| D016099 | Endoscopy, Gastrointestinal |
| D016145 | Endoscopy, Digestive System |
| D003938 | Diagnostic Techniques, Digestive System |
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|
| Push/Pull | Device | 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 | Device | 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. |
|
| 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 |
| BG001 | Push/Pull | Participants in this arm will use the Push/Pull method to administer fluid in a simulation in a simulation setting. Push/Pull: 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. |
| BG002 | Lifeflow | Participants in this arm will use the Lifeflow device to administer fluid in a simulation in a simulation setting. Lifeflow: 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. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Gender/sex was not collected for participants. | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Provider Type | Count of Participants | Participants |
|
| Patients Cared For | Patients you cared for in the last year requiring rapid volume infusion. | Count of Participants | Participants |
|
| Preferred Method | Preferred method of rapid volume infusion. | Count of Participants | Participants |
|
| Simulation Experience | Number of simulation (Sims) trainings per year. | Count of Participants | Participants |
|
| Clinical Team Member Experience | Ever worked clinical with team member? | Count of Participants | Participants |
|
| OG001 | Push/Pull | Participants in this arm will use the Push/Pull method to administer fluid in a simulation in a simulation setting. Push/Pull: 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. |
| OG002 | Lifeflow | Participants in this arm will use the Lifeflow device to administer fluid in a simulation in a simulation setting. Lifeflow: 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. |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | seconds | Up to 20 minutes |
|
|
|
| Secondary | 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. | Posted | Median | Inter-Quartile Range | score on a scale | 15 minutes |
|
|
|
| Other Pre-specified | Post Intervention Survey | A qualitative questionnaire will be administered to participants following the simulation. Questions include information about experience with various methods and other feedback relevant to evaluation. This outcome was included in the registration is actually captured by the NASA Task Load Index (TLX) that was reported. | This outcome is analyzed as the NASA Task Load Index (TLX). | Posted | 15 minutes |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Push/Pull | Participants in this arm will use the Push/Pull method to administer fluid in a simulation in a simulation setting. Push/Pull: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | Lifeflow | Participants in this arm will use the Lifeflow device to administer fluid in a simulation in a simulation setting. Lifeflow: 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. | 0 | 0 | 0 | 0 | 0 | 0 |
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| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
| D003949 | Diagnostic Techniques, Surgical |
| D013505 | Digestive System Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019060 | Minimally Invasive Surgical Procedures |
| Between 18 and 65 years |
|
| >=65 years |
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