An interventional study of ivEAD tubing kit in Infusion, sponsored by Herrick Medical LLC. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-07-11.
Sponsored by Herrick Medical LLC · Not applicable, Interventional, and Prevention
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.
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.
Exclusion Criteria:
ivEAD tubing
Device: ivEAD tubing kit
Standard tubing
ivEAD tubing
Device: ivEAD tubing kit
Standard tubing
ivEAD tubing designed to reduce infusion pump alarms do to air in infusion line
Also known as: Braun Infusomat Pump, Standard Infusion Pump
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)
Time frame: 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.
Time frame: Patients will participate in the study from the time of enrollment in the ICU for up to 3 days
Cost
Cost of disruption of nursing workflow, as measured by time-driven, activity-based costing
Time frame: 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
Time frame: Patients will participate in the study from the time of enrollment in the ICU for up to 3 days
Plan to share: No
This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.
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