Clinical trial NCT04851782: Effects of ivAED™ Device on "Air-in-line" Alarms and Workflow Disruption
Official title: Optimizing Value in Critical Care: Effect of Braun Infusomat®Space I IV Infusion Pump and ivEAD™ Air Elimination Device on "Air-in-line" Alarms and Workflow Disruption
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infusion
Keywords: Infusion
Alarms
Lead sponsor: Herrick Medical LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Southern California
First posted: 2021-04-20
Enrollment: 55
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of air-in-line IV infusion alarms (as detected by the IV infusion pump)
timeFrame: Patients will participate in the study from the time of enrollment in the ICU for up to 3 days
measure: Disruption of nursing workflow, measured as number of minutes required to attend to alarm and restore infusion flow.
timeFrame: Patients will participate in the study from the time of enrollment in the ICU for up to 3 days
Secondary outcomes:
measure: Cost
timeFrame: Patients will participate in the study from the time of enrollment in the ICU for up to 3 days
measure: Loss of Infusate
timeFrame: Patients will participate in the study from the time of enrollment in the ICU for up to 3 days
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Keck Hospital
state: California
Study officials:
affiliation: University of Southern California
name: J. Perrin Cobb, MD
role: PRINCIPAL_INVESTIGATOR
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