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

NCT04851782 | Completed FDA Device

• 1 other identifier: HM 001
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Infusion

Keywords

Infusion; Alarms

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Cost

  Patients will participate in the study from the time of enrollment in the ICU for up to 3 days

• Loss of Infusate

  Patients will participate in the study from the time of enrollment in the ICU for up to 3 days

Study Arms (4)

Braun Infusomat Pump and ivEAD tubing

EXPERIMENTAL

ivEAD tubing

Device: ivEAD tubing kit

Braun Infusomat Pump and standard tubing

NO INTERVENTION

Standard tubing

Standard pump and ivEAD tubing

EXPERIMENTAL

ivEAD tubing

Device: ivEAD tubing kit

Standard infusion pump and standard tubing

NO INTERVENTION

Standard tubing

Interventions

ivEAD tubing kit DEVICE

ivEAD tubing designed to reduce infusion pump alarms do to air in infusion line

Also known as: Braun Infusomat Pump, Standard Infusion Pump

Braun Infusomat Pump and ivEAD tubing; Standard pump and ivEAD tubing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Surgical ICU patients that are receiving IV infusions
• Patients or their surrogates have provided written, informed consent

You may not qualify if:

• Patients who do not give consent to our researchers
• Children (patients \<18 years of age)
• Pregnancy
• Prisoners

Sponsors & Collaborators

• Herrick Medical LLC: lead
• University of Southern California: collaborator

Study Sites (1)

USC Keck Hospital

Los Angeles, California, 90033, United States

Location

Related Publications (10)

• Kaplan RS, Anderson SR. Time-driven activity-based costing. Harv Bus Rev. 2004 Nov;82(11):131-8, 150.

  PMID: 15559451 BACKGROUND

• 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.

  PMID: 25647962 BACKGROUND

• 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.

  BACKGROUND

• 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

  BACKGROUND

• 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.

  PMID: 17197859 BACKGROUND

• 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.

  PMID: 28802790 BACKGROUND

• 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.

  PMID: 16319385 BACKGROUND

• Agency for Healthcare Research and Quality. Patient safety primer: Never events. https://psnet.ahrq.gov/primers/primer/3/Never-Events. Accessed August 23, 2019.

  BACKGROUND

• 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.

  PMID: 22629592 BACKGROUND

• Matocha D. Reducing infusion pump alarms through structured interventions. Journal of the Association for Vascular Access. 2018;23(2):87-95.

  BACKGROUND

Study Officials

• J. Perrin Cobb, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants either have Braun Infusomat Pump with ivEAD tubing or standard pump OR another pump with or without ivEAD tubing or standard tubing

Study Record Dates

• First Submitted: April 16, 2021
• First Posted: April 20, 2021
• Study Start: March 29, 2021
• Primary Completion: April 1, 2024
• Study Completion: June 1, 2024
• Last Updated: July 11, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)