InfusionNCT04851782
Effects of ivAED™ Device on "Air-in-line" Alarms and Workflow Disruption
A study testing ivEAD tubing kit in people with Infusion, run by Herrick Medical LLC at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infusion
- What is being tested?
- ivEAD tubing kit
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Mar 2021to 1 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Surgical ICU patients that are receiving IV infusions
- Patients or their surrogates have provided written, informed consent
Who cannot join
- Patients who do not give consent to our researchers
- Children (patients <18 years of age)
- Pregnancy
- Prisoners
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Infusion
- Being tested
- ivEAD tubing kit
- Keywords
- Infusion, Alarms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ivEAD tubing kitDevice
Also called Braun Infusomat Pump, Standard Infusion Pump
ivEAD tubing designed to reduce infusion pump alarms do to air in infusion line
| Study group | Role | What they receive |
|---|---|---|
| Braun Infusomat Pump and ivEAD tubing | Experimental | ivEAD tubing Receives: Device: ivEAD tubing kit |
| Braun Infusomat Pump and standard tubing | No intervention | Standard tubing |
| Standard pump and ivEAD tubing | Experimental | ivEAD tubing Receives: Device: ivEAD tubing kit |
| Standard infusion pump and standard tubing | No intervention | Standard tubing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: Patients will participate in the study from the time of enrollment in the ICU for up to 3 days
Secondary outcomes (2)
Cost
Cost of disruption of nursing workflow, as measured by time-driven, activity-based costing
Measured: 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
Measured: Patients will participate in the study from the time of enrollment in the ICU for up to 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start29 Mar 2021
- Primary completion1 Apr 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for InfusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herrick Medical LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University of Southern California
- Responsible party
- Sponsor
- Investigators
- J. Perrin Cobb, MD, Principal investigator, University of Southern California
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04851782
- Sponsor's protocol ID
- HM 001
- Status last verified
- Jul 2024
- First submitted
- 16 Apr 2021
- Last updated
- 11 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Kaplan RS, Anderson SR. Time-driven activity-based costing. Harv Bus Rev. 2004 Nov;82(11):131-8, 150.
PubMed 15559451Kaplan 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.
PubMed 25647962Infusion 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.
PubMed 17197859Brull 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.
PubMed 28802790Kizer 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.
PubMed 16319385Agency 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.
PubMed 22629592Matocha D. Reducing infusion pump alarms through structured interventions. Journal of the Association for Vascular Access. 2018;23(2):87-95.
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04851782
- Acronym / sponsor ID
- HM 001
- Conditions
- Infusion
- Keywords
- Infusion, Alarms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Herrick Medical LLCIndustry (pharma, biotech, devices)
- Collaborators
- University of Southern California
- Study start
- 29 Mar 2021 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 20 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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
| Arm | Type | Receives |
|---|---|---|
| Braun Infusomat Pump and ivEAD tubing | Experimental | Device: ivEAD tubing kitivEAD tubing |
| Braun Infusomat Pump and standard tubing | No intervention | –Standard tubing |
| Standard pump and ivEAD tubing | Experimental | Device: ivEAD tubing kitivEAD tubing |
| Standard infusion pump and standard tubing | No intervention | –Standard tubing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Surgical ICU patients that are receiving IV infusions
- Patients or their surrogates have provided written, informed consent
Key exclusion criteria (4 listed)
- Patients who do not give consent to our researchers
- Children (patients <18 years of age)
- Pregnancy
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ivEAD tubing kitAlso: Braun Infusomat Pump, Standard Infusion PumpivEAD tubing designed to reduce infusion pump alarms do to air in infusion line | Device | Braun Infusomat Pump and ivEAD tubing, Standard pump and ivEAD tubing |
Primary outcome
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
Number of air-in-line IV infusion alarms (as detected by the IV infusion pump)
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
Disruption of nursing workflow, measured as number of minutes required to attend to alarm and restore infusion flow.
2 secondary outcomes
Cost
Time frame: Patients will participate in the study from the time of enrollment in the ICU for up to 3 days
Loss of Infusate
Time frame: Patients will participate in the study from the time of enrollment in the ICU for up to 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2024.
- Background: PubMed 15559451Kaplan RS, Anderson SR. Time-driven activity-based costing. Harv Bus Rev. 2004 Nov;82(11):131-8, 150.
- Background: PubMed 25647962Kaplan 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.
- BackgroundInfusion 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.
- BackgroundIntravascular 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: PubMed 17197859Mirski 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.
- Background: PubMed 28802790Brull 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.
- Background: PubMed 16319385Kizer 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.
- BackgroundAgency for Healthcare Research and Quality. Patient safety primer: Never events. https://psnet.ahrq.gov/primers/primer/3/Never-Events. Accessed August 23, 2019.
- Background: PubMed 22629592Lee 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.
- BackgroundMatocha D. Reducing infusion pump alarms through structured interventions. Journal of the Association for Vascular Access. 2018;23(2):87-95.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Perrin Cobb, MD principal investigator
University of Southern California
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ivEAD tubing kit in people with Infusion, run by Herrick Medical LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04851782, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2024.