Moderate to High-risk Noncardiac SurgeryNCT05957406
SMART TRENDS Study
A study testing Acumen HPI Smart Alerts and Smart Trends Software and The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff in people with Moderate to High-risk Noncardiac Surgery, run by Becton, Dickinson and Company at 8 sites in United States.
Trial summary
A multicenter, interventional, feasibility comparison with historical controls Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Moderate to High-risk Noncardiac Surgery
- What is being tested?
- Acumen HPI Smart Alerts and Smart Trends Software and The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 296 participants
- Where
- 8 sitesUnited States
- Study dates
- 11 Jul 2023to 27 Oct 2025
- 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
- Signed informed consent
- Age ≥ 18 years
- ASA Physical Status ≥ 2
- Elective noncardiac surgery with expected surgery duration ≥ 3 hours and expected post-operative length of stay of ≥ 3 days
- Planned monitoring with an arterial catheter; Cohort 2: without planned arterial catheter insertion
- General anesthesia with tracheal intubation and positive pressure ventilation
Who cannot join
- Inability to comply with the study intra-operative hemodynamic management algorithm such as surgeon request for relative hypotension or fluid restriction or avoidance of vasopressors
- Planned vasopressor or inotrope infusion during surgery
- Contraindication to intra-arterial blood pressure monitoring
- Has previously participated in the SMART TRENDS study
- Serum creatine > 2.0 mg/dL (> 175 μmol/L) or CKD stage > 3A
- Scheduled for intracranial or cardiac surgery
Show all 14Show fewer
- Patient who is known to be pregnant
- Patients on mechanical circulatory support
- Emergency surgery
- Planned beach-chair positioning
- Additional Exclusion Criteria for Cohort 2 only:
- Extreme contraction of the smooth muscle in the arteries and arterioles of the lower arm and hand, such as may be present in patients with Raynaud's disease
- Finger or hand deformity that prevents proper placement of finger cuff by visual inspection
- Inability to place Acumen IQ finger cuffs due to subject anatomy, condition, or obstructive paraphernalia (such as false nails)
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
University of Michigan
Ann Arbor, Michigan, 48109
Henry Ford Health System
Detroit, Michigan, 48202
Duke University
Durham, North Carolina, 27705
Prisma Health
Greenville, South Carolina, 29615
Oregon Health & Science University
Portland, Oregon, 997239
UC Davis Medical Center
Sacramento, California, 95817
University of Washington
Seattle, Washington, 98195
Wake Forest Baptist Medical Center
Winston-Salem, North Carolina, 27157
About this study
Official title: Acumen HPI Smart Alerts and Smart Trends to Improve Compliance With an Intra-operative Hemodynamic Management Algorithm and Reduce Renal Injury Following Major Elective Noncardiac Surgery.
A multicenter, interventional, feasibility comparison with historical controls
- Conditions
- Moderate to High-risk Noncardiac Surgery
- Being tested
- Acumen HPI Smart Alerts and Smart Trends Software, The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acumen HPI Smart Alerts and Smart Trends SoftwareDevice
Device: Acumen HPI Smart Alerts and Smart Trends Software The Acumen HPI Smart Alerts and Smart Trends Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The Acumen HPI Smart Alerts and Smart Trends Software suite is enabled by the minimally invasive Acumen IQ sensor.
The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuffDevice
Device: HemoSphere ClearSight Module and Pressure Controller, and adult Acumen IQ finger cuff
| Study group | Role | What they receive |
|---|---|---|
| SMART TRENDS - Acumen IQ Sensor | Other | Acumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery. Receives: Device: Acumen HPI Smart Alerts and Smart Trends Software |
| SMART TRENDS - Acumen IQ Cuff | Other | Acumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery. Receives: Device: The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff |
What is being measured
The primary outcome is the main question the study is designed to answer.
HPI Smart Alert
The proportion of HPI Smart Alert prompts displayed resulting in initiation of action within 5 minutes consistent with an intra-operative hemodynamic management algorithm.
Measured: From start to end of non-cardiac surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2023
- Study start11 Jul 2023
- Primary completion27 Oct 2025
- Study completion27 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Moderate to High-risk Noncardiac SurgeryStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- HemoSphere Advanced Monitor with Acumen Hypotension Prediction Index (HPI) software feature, and Acumen IQ sensor
- Masking
- None (open label)
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Becton, Dickinson and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05957406
- Sponsor's protocol ID
- 2023-05
- Status last verified
- Jul 2026
- First submitted
- 14 Jul 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Guerra-Londono CE, Hand WR, Fleming N, Davis J, Treggiari MM, Dunkman WJ, Kumar SS, Khanna AK, Yang JT, Domino KB. Hypotension prediction index smart alerts and trends to improve compliance with goal-directed hemodynamic therapy: a feasibility study. BMC Anesthesiol. 2025 Sep 30;25(1):471. doi: 10.1186/s12871-025-03336-z.
PubMed 41029588
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acumen HPI Smart Alerts and Smart Trends to Improve Compliance With an Intra-operative Hemodynamic Management Algorithm and Reduce Renal Injury Following Major Elective Noncardiac Surgery.
- ClinicalTrials.gov ID
- NCT05957406
- Acronym / sponsor ID
- 2023-05
- Conditions
- Moderate to High-risk Noncardiac Surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Becton, Dickinson and CompanyIndustry (pharma, biotech, devices)
- Study start
- 11 Jul 2023 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 27 Oct 2025 (actual)
- First posted
- 24 Jul 2023 (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.
A multicenter, interventional, feasibility comparison with historical controls
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- HemoSphere Advanced Monitor with Acumen Hypotension Prediction Index (HPI) software feature, and Acumen IQ sensor
| Arm | Type | Receives |
|---|---|---|
| SMART TRENDS - Acumen IQ Sensor | Other | Device: Acumen HPI Smart Alerts and Smart Trends SoftwareAcumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery. |
| SMART TRENDS - Acumen IQ Cuff | Other | Device: The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuffAcumen HPI Smart Alerts and Smart Trends Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent
- Age ≥ 18 years
- ASA Physical Status ≥ 2
- Elective noncardiac surgery with expected surgery duration ≥ 3 hours and expected post-operative length of stay of ≥ 3 days
- Planned monitoring with an arterial catheter; Cohort 2: without planned arterial catheter insertion
Key exclusion criteria (14 listed)
- Inability to comply with the study intra-operative hemodynamic management algorithm such as surgeon request for relative hypotension or fluid restriction or avoidance of vasopressors
- Planned vasopressor or inotrope infusion during surgery
- Contraindication to intra-arterial blood pressure monitoring
- Has previously participated in the SMART TRENDS study
- Serum creatine > 2.0 mg/dL (> 175 μmol/L) or CKD stage > 3A
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 |
|---|---|---|
| Acumen HPI Smart Alerts and Smart Trends SoftwareDevice: Acumen HPI Smart Alerts and Smart Trends Software The Acumen HPI Smart Alerts and Smart Trends Software provides the clinician with physiological insight into a patient's likelihood of trending toward a hypotensive event. The Acumen HPI Smart Alerts and Smart Trends Software suite is enabled by the minimally invasive Acumen IQ sensor. | Device | SMART TRENDS - Acumen IQ Sensor |
| The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuffDevice: HemoSphere ClearSight Module and Pressure Controller, and adult Acumen IQ finger cuff | Device | SMART TRENDS - Acumen IQ Cuff |
Primary outcome
HPI Smart Alert
Time frame: From start to end of non-cardiac surgery
The proportion of HPI Smart Alert prompts displayed resulting in initiation of action within 5 minutes consistent with an intra-operative hemodynamic management algorithm.
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 8 Jul 2026.
- Derived from this study: PubMed 41029588Guerra-Londono CE, Hand WR, Fleming N, Davis J, Treggiari MM, Dunkman WJ, Kumar SS, Khanna AK, Yang JT, Domino KB. Hypotension prediction index smart alerts and trends to improve compliance with goal-directed hemodynamic therapy: a feasibility study. BMC Anesthesiol. 2025 Sep 30;25(1):471. doi: 10.1186/s12871-025-03336-z.
- Individual participant dataSharing planned: No
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Postoperative Delirium, Major Noncardiac Surgery
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.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Acumen HPI Smart Alerts and Smart Trends Software and The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff in people with Moderate to High-risk Noncardiac Surgery, run by Becton, Dickinson and Company at 8 sites 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 6 inclusion and 14 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 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
HPI Smart Alert (time frame: From start to end of non-cardiac surgery). 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 NCT05957406, which also lists 1 linked publication.
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 8 Jul 2026.