Effects of ivAED™ Device on Air-in-line Alarms and Workflow Disruption

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Infusion

Intervention / Treatment
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* Device: ivEAD tubing kit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Braun Infusomat Pump and ivEAD tubing<br>ivEAD tubing | Device: ivEAD tubing kit<br>* ivEAD tubing designed to reduce infusion pump alarms do to air in infusion line<br>* Other names: Standard Infusion Pump;|
| No Intervention: Braun Infusomat Pump and standard tubing<br>Standard tubing | |
| Experimental: Standard pump and ivEAD tubing<br>ivEAD tubing | Device: ivEAD tubing kit<br>* ivEAD tubing designed to reduce infusion pump alarms do to air in infusion line<br>* Other names: Standard Infusion Pump;|
| No Intervention: Standard infusion pump and standard tubing<br>Standard tubing | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of air-in-line IV infusion alarms (as detected by the IV infusion pump) | 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 | 
| Disruption of nursing workflow, measured as number of minutes required to attend to alarm and restore infusion flow. | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost | Cost of disruption of nursing workflow, as measured by time-driven, activity-based costing | Patients will participate in the study from the time of enrollment in the ICU for up to 3 days | 
| Loss of Infusate | Loss of infusate secondary to clearance of air in line | Patients will participate in the study from the time of enrollment in the ICU for up to 3 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Infusion, Alarms