Acumen IQ cuff and Acumen HPI software

About the Trial

The HPI Smart-BP trial is a multicenter, interventional, randomized trial to determine if the use of Acumen Hypotension Prediction Index (HPI) software in combination with a hemodynamic protocol for intraoperative hemodynamic management reduces postoperative complication rates in (HPI) software guidance for intraoperative hemodynamic management reduces postoperative complication rates in moderate- to high-risk noncardiac surgery.

Risks of Hypotension

There is accumulating evidence that intraoperative hypotension, or low blood pressure, is associated with injury to the heart and kidney, and carries an increased likelihood of mortality in moderate- to high-risk patients.

Acumen IQ cuff and Acumen HPI software
Acumen IQ cuff and Acumen HPI software

The Technology

Acumen HPI software provides the clinician with physiological insight into the likelihood of a patient trending towards a hypotensive event (defined as mean arterial pressure (MAP) < 65 mmHg for at least one minute) and the associated hemodynamic parameters. Acumen HPI software is intended for use in surgical and non-surgical patients receiving advanced hemodynamic monitoring. Acumen HPI software is used as decision support to supplement the clinician’s assessment of the patient’s physiological condition. No therapeutic decisions should be made based solely on Acumen HPI parameter.

Acumen HPI software, on HemoSphere advanced monitoring platform, is enabled by minimally-invasive Acumen IQ sensor. Acumen IQ sensor connects to an existing radial arterial line. Hemodynamic information is calculated and presented on HemoSphere advanced monitoring platform. The entire system is comprised of:

  • Acumen IQ sensor: The sensor is connected to the existing arterial catheter tubing from the patient. The sensor relays information to the standard anesthesia monitor in the form of continuous arterial pressure waveform. The sensor also relays information to Acumen HPI software-enabled HemoSphere monitor.
  • ForeSight sensor continuously monitors cerebration oxygen saturation noninvasively.
  • Acumen HPI software: The software consists of Hypotension Prediction Index parameter and other advanced hemodynamic parameters.
  • HemoSphere monitor: This is the monitor which displays the continuous arterial pressure monitoring, HPI parameter, and other advanced hemodynamic parameters.

Patient eligibility

Inclusion criteria:

  1. Signed informed consent
  2. Age ≥ 18 years
  3. ASA Physical Status ≥ 2
  4. Noncardiac surgery with expected surgery duration ≥ 2 hours (example include: orthopedic, spine, urology, and general surgery)
  5. Planned blood pressure monitoring with an arterial line catheter
  6. General anesthesia

Exclusion criteria:

  1. Participating in another interventional trial
  2. Contraindication to arterial blood pressure monitoring
  3. Subjects with a physical site area too limited for proper sensor placement
  4. Serum creatine > 175 µmol/L (>2.0 rng/dL) or CKD stage > 3A
  5. Scheduled for intracranial surgery with permissive hypotension
  6. Patient who is confirmed to be pregnant and/or nursing mothers
  7. Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s)(VAD)
  8. Have a condition that precludes routine or tight blood pressure management such as surgeron request for relative hypotension
  9. Emergency surgery
  10. Require beach-chair positioning
  11. Scheduled for cardiac surgeries
  12. Have previously participated in the SMART-BP trial

Cohort design

Patients will be randomized using a 1:1 ratio to either the Acumen HPI treatment arm or the standard of care control arm.

Acumen IQ cuff and Acumen HPI software
Support Agent

We’re here for you

We are committed to providing the highest levels of customer service to help our patients improve their quality of life. For any questions, please contact the Edwards Patient Support Center. For details about the trial, visit NCT05105477at Clinical Trials.gov.

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Important safety information

CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician.
See Instructions For Use (IFU) / Directions For Use (DFU) for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

Important safety information

CAUTION: Federal (United States) law restricts this device to sale by or on the order of a physician.
See Instructions For Use (IFU) / Directions For Use (DFU) for full prescribing information, including indications, contraindications, warnings, precautions and adverse events.

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