Infusion
Conditions
Keywords
Infusion, Alarms
Brief summary
The investigators propose to test the hypothesis, that is, the effectiveness of the ivAED to eliminate air-in-line, comparing two commercially available, standard IV infusion pumps: the Braun Infusomat® Space P and the Becton-Dickenson Alaris™ model 8100 pump (the latter is currently in use as the standard IV infusion pump at Keck Hospital of USC). Testing of an IV infusion pump other the Keck Hospital of USC standard is indicated, as the independent laboratory testing of the Alaris™ 8100 pump found that this model pump is prone to developing air bubbles as the infusion passes through the pump mechanism. These air bubbles can be sufficient to trigger the air-in-line alarm. The Braun Infusomat® Space P IV infusion pump is a market leader like the Alaris™ 8100 pump, was evaluated in independent testing with and without the ivAED™ device, and was NOT found to create bubbles.
Detailed description
There are very few controlled human studies in the literature that assess various existing preventative measures for air embolism. After extensive, independent pre-clinical laboratory testing of the ivAED™ device demonstrating efficacy in removing air-in-line from IV infusions (see Appendix 1), this is the first-in-humans, clinical application of the ivAED™ device. Testing of the ivAED™ device in patients is justified as that is the only means to determine the impact of the device on clinical IV infusion and nursing workflow disruptions (the primary outcomes of the study). Testing of the device in animals, or in healthy volunteers, or in computer simulations cannot provide this real-world information. In addition, the FDA typically requires that laboratory pre-clinical testing be coupled with clinical testing when applying for approval of new, investigational devices. The investigators propose to test the hypothesis, that is, the effectiveness of the ivAED to eliminate air-in-line, comparing two commercially available, standard IV infusion pumps: the Braun Infusomat® Space P and the Becton-Dickenson Alaris™ model 8100 pump (the latter is currently in use as the standard IV infusion pump at Keck Hospital of USC). Testing of an IV infusion pump other the Keck Hospital of USC standard is indicated, as the independent laboratory testing of the Alaris™ 8100 pump found that this model pump is prone to developing air bubbles as the infusion passes through the pump mechanism. These air bubbles can be sufficient to trigger the air-in-line alarm. The Braun Infusomat® Space P IV infusion pump is a market leader like the Alaris™ 8100 pump, was evaluated in independent testing with and without the ivAED™ device, and was NOT found to create bubbles.
Interventions
DEVICEivEAD tubing kit
ivEAD tubing designed to reduce infusion pump alarms do to air in infusion line
Sponsors
University of Southern California
Herrick Medical LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Participants either have Braun Infusomat Pump with ivEAD tubing or standard pump OR another pump with or without ivEAD tubing or standard tubing
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Surgical ICU patients that are receiving IV infusions * Patients or their surrogates have provided written, informed consent
Exclusion criteria
* Patients who do not give consent to our researchers * Children (patients \<18 years of age) * Pregnancy * Prisoners
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of air-in-line IV infusion alarms (as detected by the IV infusion pump) | Patients will participate in the study from the time of enrollment in the ICU for up to 3 days | Number of air-in-line IV infusion alarms (as detected by the IV infusion pump) |
| Disruption of nursing workflow, measured as number of minutes required to attend to alarm and restore infusion flow. | Patients will participate in the study from the time of enrollment in the ICU for up to 3 days | Disruption of nursing workflow, measured as number of minutes required to attend to alarm and restore infusion flow. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cost | Patients will participate in the study from the time of enrollment in the ICU for up to 3 days | Cost of disruption of nursing workflow, as measured by time-driven, activity-based costing |
| Loss of Infusate | Patients will participate in the study from the time of enrollment in the ICU for up to 3 days | Loss of infusate secondary to clearance of air in line |
Countries
United States
Outcome results
None listed