Smart Monitoring Software for Noncardiac Surgery Outcomes

Recruiting at 8 trial locations

Overseen By Cristina Johnson

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Edwards Lifesciences

Must not be taking: Vasopressors, Inotropes

Disqualifiers: Pregnancy, CKD stage > 3A, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: Duration of surgery

244 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Acumen HPI software for noncardiac surgery outcomes?

The Acumen HPI software, which uses artificial intelligence to predict low blood pressure during surgery, has been shown to reduce the severity and duration of low blood pressure in patients undergoing non-cardiac surgery. Studies indicate that patients monitored with this software experienced fewer complications and shorter hospital stays. ^{1 2 3 4 5}

Is the Acumen Hypotension Prediction Index software safe for use in humans?

The available research does not specifically address the safety of the Acumen Hypotension Prediction Index software, but it is used to predict and manage low blood pressure during surgery, which can help prevent complications. ^{1 2 3 6 7}

How does the Smart Monitoring Software treatment differ from other treatments for noncardiac surgery outcomes?

The Smart Monitoring Software, specifically the Acumen™ Hypotension Prediction Index (HPI) software, is unique because it uses artificial intelligence to predict and prevent intraoperative hypotension (low blood pressure during surgery) by analyzing blood pressure waveforms. This proactive approach contrasts with traditional methods that react to hypotension after it occurs, potentially reducing complications and improving patient outcomes during noncardiac surgeries. ^{1 2 3 5 8}

What is the purpose of this trial?

A multicenter, interventional, feasibility comparison with historical controls

Research Team

Tina Abdelnour, MS, BSN

Principal Investigator

Edwards Lifesciences

Eligibility Criteria

The SMART TRENDS Study is for adults over 18 who are undergoing elective noncardiac surgery expected to last at least 3 hours with a post-op hospital stay of at least 3 days. Participants must be monitored with an arterial catheter under general anesthesia. Those with planned vasopressor use, contraindications to arterial monitoring, severe kidney issues, or on mechanical support can't join.

Inclusion Criteria

Signed informed consent

I will be under general anesthesia with a breathing tube for my surgery.

I am scheduled for a non-heart surgery that will last 3 hours or more and will stay in the hospital for at least 3 days after.

Exclusion Criteria

My kidney function is reduced, with creatinine over 2.0 mg/dL or CKD stage above 3A.

Patients on mechanical circulatory support

I need surgery urgently.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo intra-operative hemodynamic management using Acumen HPI Smart Alerts and Smart Trends during non-cardiac surgery

Duration of surgery

Follow-up

Participants are monitored for renal injury and compliance with hemodynamic management post-surgery

4 weeks

Treatment Details

Interventions

• Acumen HPI

Trial Overview This study tests the Acumen HPI Smart Alerts and Smart Trends Software in patients having noncardiac surgery. It's a multicenter trial comparing outcomes using this software against past data from surgeries without it.

Participant Groups

Group I: SMART TRENDS - Acumen IQ Sensor Experimental Treatment 1 Intervention

Acumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.

Group II: SMART TRENDS - Acumen IQ Cuff Experimental Treatment 1 Intervention

Acumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.

Who Is Running the Clinical Trial?

Edwards Lifesciences

Lead Sponsor

Trials

188

Recruited

67,500+

Founded

1958

Headquarters

Irvine, California, U.S.

Known For

Structural Heart Innovations

Top Products

SAPIEN Transcatheter Heart Valve, EVOQUE System, PASCAL Precision, SAPIEN M3

Todd Brinton

Edwards Lifesciences

Chief Medical Officer since 2023

MD from Stanford University

Bernard Zovighian

Edwards Lifesciences

Chief Executive Officer since 2023

MBA from INSEAD

Findings from Research

In a study involving 749 patients undergoing elective major noncardiac surgery, the use of the Acumen™ Hypotension Prediction Index (HPI) software resulted in a very low median time-weighted average mean arterial pressure (MAP) below 65 mm Hg, indicating effective monitoring and management of intraoperative hypotension.

The findings showed that 41% of patients did not experience any episodes of MAP <65 mm Hg, and those who did had a median of only 1 episode lasting a median of 2 minutes, suggesting that HPI software may significantly reduce the incidence and severity of intraoperative hypotension.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intraoperative hypotension when using hypotension prediction index software during major noncardiac surgery: a European multicentre prospective observational registry (EU HYPROTECT). Kouz, K., Monge García, MI., Cerutti, E., et al.[2023]

A multicenter, prospective registry study is being conducted across five European countries to evaluate the incidence and characteristics of intraoperative hypotension in over 700 patients undergoing elective major non-cardiac surgery using the Acumen Hypotension Prediction Index (HPI) software.

The study aims to quantify hypotension events defined as a mean arterial pressure (MAP) below 65 mmHg, and to explore the relationship between these events and postoperative outcomes, addressing a significant gap in current knowledge about intraoperative management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypotension Prediction Index Software to Prevent Intraoperative Hypotension during Major Non-Cardiac Surgery: Protocol for a European Multicenter Prospective Observational Registry (EU-HYPROTECT). Monge García, MI., García-López, D., Gayat, É., et al.[2023]

The Hypotension Prediction Index (HPI) effectively predicts and helps prevent intraoperative hypotension, as demonstrated in a case involving an 84-year-old woman undergoing major spinal surgery without the option for blood transfusions.

Utilizing the HPI-based treatment algorithm resulted in high hemodynamic stability during surgery, minimizing the risk of hypotension and avoiding complications related to blood volume management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of artificial intelligence and machine learning monitoring to safely administer a fluid-restrictive goal-directed treatment protocol to minimize the risk of transfusion during major spine surgery of a Jehovah's Witness: a case report. Denn, S., Schneck, E., Jablawi, F., et al.[2022]

The Hypotension Prediction Index (HPI) algorithm can predict intraoperative hypotension before it occurs, potentially allowing for proactive treatment rather than reactive measures, which could improve patient outcomes during surgery.

This study will involve 100 adult patients undergoing non-cardiac surgery, with the goal of reducing the time spent in hypotension by using the HPI algorithm to guide treatment, comparing results from a randomized controlled trial design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of a machine-learning algorithm that predicts hypotension during surgery in combination with personalized treatment guidance: study protocol for a randomized clinical trial. Wijnberge, M., Schenk, J., Terwindt, LE., et al.[2020]

The Hypotension Prediction Index (HPI) significantly reduced the time-weighted average of hypotension (TWAMAP<65) during surgery, indicating better management of intraoperative arterial hypotension compared to standard treatment protocols.

Patients managed with the HPI experienced fewer postoperative complications and had a shorter length of hospital stay, suggesting that the HPI combined with goal-directed fluid therapy can enhance patient outcomes in non-cardiac surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-world outcomes of the hypotension prediction index in the management of intraoperative hypotension during non-cardiac surgery: a retrospective clinical study. Solares, GJ., Garcia, D., Monge Garcia, MI., et al.[2023]

The use of the Hypotension Prediction Index (HPI) algorithm significantly reduced the number and duration of hypotensive events in 34 patients undergoing major thoracic surgeries compared to traditional monitoring methods, indicating its potential for improving patient safety during surgery.

While the HPI group experienced fewer hypotensive events, there were no significant differences in overall clinical outcomes such as laboratory results or hospital stay, suggesting that further research is needed to fully understand the clinical benefits of HPI-guided monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypotension prediction index guided versus conventional goal directed therapy to reduce intraoperative hypotension during thoracic surgery: a randomized trial. Šribar, A., Jurinjak, IS., Almahariq, H., et al.[2023]

The hypotension probability indicator (HPI) demonstrated a fair ability to predict hypotensive events during surgery, with an area under the curve of 0.768, indicating it can be somewhat effective in identifying patients at risk.

An HPI value of 85% or lower suggests a 'safe zone' with a high negative predictive value (97.8%), while values above 98% strongly indicate an impending hypotensive event, although higher values do not reliably predict the need for immediate intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Discrimination and calibration properties of the hypotension probability indicator during cardiac and vascular surgery. Ranucci, M., Barile, L., Ambrogi, F., et al.[2020]

The Hypotension Prediction Index (HPI) algorithm effectively predicts intra-operative hypotension using noninvasive continuous arterial blood pressure (ABP) measurements, showing similar performance to invasive methods in a study of 507 adult patients undergoing general surgery.

At an HPI alarm threshold of 85, the algorithm demonstrated high sensitivity (92.7%) and negative predictive value (95.8%), indicating it can reliably alert clinicians to potential hypotension, thus allowing for timely interventions to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical performance of a machine-learning algorithm to predict intra-operative hypotension with noninvasive arterial pressure waveforms: A cohort study. Wijnberge, M., van der Ster, BJP., Geerts, BF., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Intraoperative hypotension when using hypotension prediction index software during major noncardiac surgery: a European multicentre prospective observational registry (EU HYPROTECT). [2023]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Hypotension Prediction Index Software to Prevent Intraoperative Hypotension during Major Non-Cardiac Surgery: Protocol for a European Multicenter Prospective Observational Registry (EU-HYPROTECT). [2023]

3. England pubmed.ncbi.nlm.nih.gov

The use of artificial intelligence and machine learning monitoring to safely administer a fluid-restrictive goal-directed treatment protocol to minimize the risk of transfusion during major spine surgery of a Jehovah's Witness: a case report. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The use of a machine-learning algorithm that predicts hypotension during surgery in combination with personalized treatment guidance: study protocol for a randomized clinical trial. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Real-world outcomes of the hypotension prediction index in the management of intraoperative hypotension during non-cardiac surgery: a retrospective clinical study. [2023]

6. England pubmed.ncbi.nlm.nih.gov

Hypotension prediction index guided versus conventional goal directed therapy to reduce intraoperative hypotension during thoracic surgery: a randomized trial. [2023]

7. Italy pubmed.ncbi.nlm.nih.gov

Discrimination and calibration properties of the hypotension probability indicator during cardiac and vascular surgery. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Clinical performance of a machine-learning algorithm to predict intra-operative hypotension with noninvasive arterial pressure waveforms: A cohort study. [2021]