Trial Outcomes & Findings for Novel Device for Rapid Fluid Administration (NCT NCT03074682)
NCT ID: NCT03074682
Last Updated: 2019-01-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
54 participants
Primary outcome timeframe
20 minutes
Results posted on
2019-01-31
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
18
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Gender/sex was not collected for participants.
Baseline characteristics by cohort
| Measure |
Pressure Bag
n=18 Participants
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.
|
Push/Pull
n=18 Participants
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.
|
Lifeflow
n=18 Participants
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.
|
Total
n=54 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=54 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
18 Participants
n=18 Participants
|
54 Participants
n=54 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=54 Participants
|
|
Sex: Female, Male
Female
|
—
|
—
|
—
|
0 Participants
Gender/sex was not collected for participants.
|
|
Sex: Female, Male
Male
|
—
|
—
|
—
|
0 Participants
Gender/sex was not collected for participants.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
18 participants
n=18 Participants
|
18 participants
n=18 Participants
|
18 participants
n=18 Participants
|
54 participants
n=54 Participants
|
|
Provider Type
MD - Fellow
|
2 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=54 Participants
|
|
Provider Type
MD - Resident
|
7 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
7 Participants
n=18 Participants
|
22 Participants
n=54 Participants
|
|
Provider Type
MD - Attending
|
0 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
3 Participants
n=54 Participants
|
|
Provider Type
Paramedic
|
1 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
3 Participants
n=54 Participants
|
|
Provider Type
RN
|
8 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
24 Participants
n=54 Participants
|
|
Patients Cared For
0
|
0 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
2 Participants
n=54 Participants
|
|
Patients Cared For
1-5
|
8 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
24 Participants
n=54 Participants
|
|
Patients Cared For
6-10
|
3 Participants
n=18 Participants
|
3 Participants
n=18 Participants
|
4 Participants
n=18 Participants
|
10 Participants
n=54 Participants
|
|
Patients Cared For
> 10
|
7 Participants
n=18 Participants
|
6 Participants
n=18 Participants
|
5 Participants
n=18 Participants
|
18 Participants
n=54 Participants
|
|
Preferred Method
Pressure Bag
|
7 Participants
n=18 Participants
|
7 Participants
n=18 Participants
|
6 Participants
n=18 Participants
|
20 Participants
n=54 Participants
|
|
Preferred Method
Push/Pull
|
4 Participants
n=18 Participants
|
7 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
19 Participants
n=54 Participants
|
|
Preferred Method
Rapid Infuser
|
2 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
3 Participants
n=54 Participants
|
|
Preferred Method
Pump/Smart Pump
|
4 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
1 Participants
n=18 Participants
|
7 Participants
n=54 Participants
|
|
Preferred Method
Syringe
|
0 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=54 Participants
|
|
Preferred Method
MISSING
|
1 Participants
n=18 Participants
|
0 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
3 Participants
n=54 Participants
|
|
Simulation Experience
> 5 Sims per Year
|
7 Participants
n=18 Participants
|
10 Participants
n=18 Participants
|
9 Participants
n=18 Participants
|
26 Participants
n=54 Participants
|
|
Simulation Experience
1 -5 Sims per Year
|
11 Participants
n=18 Participants
|
8 Participants
n=18 Participants
|
9 Participants
n=18 Participants
|
28 Participants
n=54 Participants
|
|
Clinical Team Member Experience
Yes
|
16 Participants
n=18 Participants
|
16 Participants
n=18 Participants
|
16 Participants
n=18 Participants
|
48 Participants
n=54 Participants
|
|
Clinical Team Member Experience
No
|
2 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
2 Participants
n=18 Participants
|
6 Participants
n=54 Participants
|
PRIMARY outcome
Timeframe: 20 minutesParticipants 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.
Outcome measures
| Measure |
Pressure Bag
n=18 Participants
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.
|
Push/Pull
n=18 Participants
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.
|
Lifeflow
n=18 Participants
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.
|
|---|---|---|---|
|
Successful Administration of 60 mL/kg
|
14 Participants
|
18 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: Up to 20 minutesParticipants 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.
Outcome measures
| Measure |
Pressure Bag
n=18 Participants
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.
|
Push/Pull
n=18 Participants
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.
|
Lifeflow
n=18 Participants
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.
|
|---|---|---|---|
|
Time to Complete Fluid Administration
|
718.9 seconds
Standard Deviation 57.3
|
519.4 seconds
Standard Deviation 26.3
|
376.5 seconds
Standard Deviation 30.4
|
SECONDARY outcome
Timeframe: 15 minutesThe 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.
Outcome measures
| Measure |
Pressure Bag
n=18 Participants
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.
|
Push/Pull
n=18 Participants
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.
|
Lifeflow
n=18 Participants
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.
|
|---|---|---|---|
|
NASA Task Load Index (TLX)
Composite
|
42.50 score on a scale
Interval 22.08 to 54.79
|
40.42 score on a scale
Interval 22.29 to 48.13
|
30.00 score on a scale
Interval 22.08 to 38.33
|
|
NASA Task Load Index (TLX)
Mental
|
60.00 score on a scale
Interval 43.75 to 75.0
|
57.50 score on a scale
Interval 31.25 to 68.78
|
37.50 score on a scale
Interval 20.0 to 50.0
|
|
NASA Task Load Index (TLX)
Physical
|
20.00 score on a scale
Interval 5.0 to 57.5
|
22.50 score on a scale
Interval 11.25 to 53.75
|
20.00 score on a scale
Interval 5.0 to 50.0
|
|
NASA Task Load Index (TLX)
Temporal
|
55.00 score on a scale
Interval 30.0 to 71.25
|
62.50 score on a scale
Interval 31.25 to 75.0
|
35.00 score on a scale
Interval 23.75 to 51.25
|
|
NASA Task Load Index (TLX)
Performance
|
27.50 score on a scale
Interval 20.0 to 47.5
|
22.50 score on a scale
Interval 10.0 to 37.5
|
25.00 score on a scale
Interval 20.0 to 30.0
|
|
NASA Task Load Index (TLX)
Effort
|
57.50 score on a scale
Interval 30.0 to 75.0
|
50.00 score on a scale
Interval 33.75 to 65.0
|
40.00 score on a scale
Interval 20.0 to 56.25
|
|
NASA Task Load Index (TLX)
Frustration
|
15.00 score on a scale
Interval 5.0 to 40.0
|
17.50 score on a scale
Interval 6.25 to 30.0
|
12.50 score on a scale
Interval 5.0 to 17.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 15 minutesPopulation: This outcome is analyzed as the NASA Task Load Index (TLX).
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.
Outcome measures
Outcome data not reported
Adverse Events
Pressure Bag
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Push/Pull
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Lifeflow
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place