NCT03074682

Novel Device for Rapid Fluid Administration

Completed NA Results posted Last updated 31 January 2019

What this trial tests

NA trial testing Lifeflow in Device Related Sepsis in 54 participants. Completed in 15 June 2017.

Timeline

1 February 2017

Primary endpoint
15 June 2017

15 June 2017

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	54
Start date	1 February 2017
Primary completion	15 June 2017
Estimated completion	15 June 2017
Sites	1 location across United States

Drugs / interventions tested

• Lifeflow
• Push/Pull
• Pressure Bag

Conditions studied

• Device Related Sepsis — all drugs for Device Related Sepsis →

Sponsor

Yale University

Who can join

Eligibility, any sex, with Device Related Sepsis. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Successful Administration of 60 mL/kg Primary · 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.

Group	Value	95% CI
Pressure Bag	14
Push/Pull	18
Lifeflow	16

Time to Complete Fluid Administration Secondary · Up to 20 minutes

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.

Group	Value	95% CI
Pressure Bag	718.9	± 57.3
Push/Pull	519.4	± 26.3
Lifeflow	376.5	± 30.4

NASA Task Load Index (TLX) Secondary · 15 minutes

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.

Composite

Group	Value	95% CI
Pressure Bag	42.50	22.08 – 54.79
Push/Pull	40.42	22.29 – 48.13
Lifeflow	30.00	22.08 – 38.33

Mental

Group	Value	95% CI
Pressure Bag	60.00	43.75 – 75.00
Push/Pull	57.50	31.25 – 68.78
Lifeflow	37.50	20.00 – 50.00

Physical

Group	Value	95% CI
Pressure Bag	20.00	5.00 – 57.50
Push/Pull	22.50	11.25 – 53.75
Lifeflow	20.00	5.00 – 50.00

Temporal

Group	Value	95% CI
Pressure Bag	55.00	30.00 – 71.25
Push/Pull	62.50	31.25 – 75.00
Lifeflow	35.00	23.75 – 51.25

Performance

Group	Value	95% CI
Pressure Bag	27.50	20.00 – 47.50
Push/Pull	22.50	10.00 – 37.50
Lifeflow	25.00	20.00 – 30.00

Effort

Group	Value	95% CI
Pressure Bag	57.50	30.00 – 75.00
Push/Pull	50.00	33.75 – 65.00
Lifeflow	40.00	20.00 – 56.25

Frustration

Group	Value	95% CI
Pressure Bag	15.00	5.00 – 40.00
Push/Pull	17.50	6.25 – 30.00
Lifeflow	12.50	5.00 – 17.50

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.