Effects of ivAED™ Device on "Air-in-line" Alarms and Workflow Disruption
NCT ID: NCT04851782
Last Updated: 2024-07-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
55 participants
INTERVENTIONAL
2021-03-29
2024-06-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Braun Infusomat Pump and ivEAD tubing
ivEAD tubing
ivEAD tubing kit
ivEAD tubing designed to reduce infusion pump alarms do to air in infusion line
Braun Infusomat Pump and standard tubing
Standard tubing
No interventions assigned to this group
Standard pump and ivEAD tubing
ivEAD tubing
ivEAD tubing kit
ivEAD tubing designed to reduce infusion pump alarms do to air in infusion line
Standard infusion pump and standard tubing
Standard tubing
No interventions assigned to this group
Interventions
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ivEAD tubing kit
ivEAD tubing designed to reduce infusion pump alarms do to air in infusion line
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients or their surrogates have provided written, informed consent
Exclusion Criteria
* Children (patients \<18 years of age)
* Pregnancy
* Prisoners
18 Years
ALL
No
Sponsors
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University of Southern California
OTHER
Herrick Medical LLC
INDUSTRY
Responsible Party
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Principal Investigators
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J. Perrin Cobb, MD
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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USC Keck Hospital
Los Angeles, California, United States
Countries
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References
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Kaplan RS, Anderson SR. Time-driven activity-based costing. Harv Bus Rev. 2004 Nov;82(11):131-8, 150.
Kaplan RS, Witkowski M, Abbott M, Guzman AB, Higgins LD, Meara JG, Padden E, Shah AS, Waters P, Weidemeier M, Wertheimer S, Feeley TW. Using time-driven activity-based costing to identify value improvement opportunities in healthcare. J Healthc Manag. 2014 Nov-Dec;59(6):399-412.
Infusion pump market is anticipated to exceed US$ 49 billion by 2025. https://www.marketwatch.com/press-release/infusion-pump-market-is-anticipated-to-exceed-us-49-billion-by-2025-2019-03-28. Updated 2019. Accessed August 23, 2019.
Intravascular air-in-line and air embolism risks associated with infusion pumps, fluid warmers, and rapid infusers: FDA safety communication. U.S. Food and Drug Administration. 2019
Mirski MA, Lele AV, Fitzsimmons L, Toung TJ. Diagnosis and treatment of vascular air embolism. Anesthesiology. 2007 Jan;106(1):164-77. doi: 10.1097/00000542-200701000-00026.
Brull SJ, Prielipp RC. Vascular air embolism: A silent hazard to patient safety. J Crit Care. 2017 Dec;42:255-263. doi: 10.1016/j.jcrc.2017.08.010. Epub 2017 Aug 7.
Kizer JR, Devereux RB. Clinical practice. Patent foramen ovale in young adults with unexplained stroke. N Engl J Med. 2005 Dec 1;353(22):2361-72. doi: 10.1056/NEJMcp043981. No abstract available.
Agency for Healthcare Research and Quality. Patient safety primer: Never events. https://psnet.ahrq.gov/primers/primer/3/Never-Events. Accessed August 23, 2019.
Lee PT, Thompson F, Thimbleby H. Analysis of infusion pump error logs and their significance for health care. Br J Nurs. 2012 Apr 26-May 9;21(8):S12, S14, S16-20. doi: 10.12968/bjon.2012.21.Sup8.S12.
Matocha D. Reducing infusion pump alarms through structured interventions. Journal of the Association for Vascular Access. 2018;23(2):87-95.
Other Identifiers
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HM 001
Identifier Type: -
Identifier Source: org_study_id
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