Moderate to High-risk Noncardiac Surgery
Conditions
Brief summary
A multicenter, interventional, feasibility comparison with historical controls
Interventions
DEVICEAcumen HPI Smart Alerts and Smart Trends Software
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.
DEVICEThe HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff
Device: HemoSphere ClearSight Module and Pressure Controller, and adult Acumen IQ finger cuff
Sponsors
Becton, Dickinson and Company
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
OTHER
Masking
NONE
Masking description
HemoSphere ClearSight Module and Pressure Controller, and adult Acumen IQ finger cuff
Intervention model description
HemoSphere Advanced Monitor with Acumen Hypotension Prediction Index (HPI) software feature, and Acumen IQ sensor
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * Patient who is known to be pregnant * Patients on mechanical circulatory support * Emergency surgery * Planned beach-chair positioning Additional
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| HPI Smart Alert | 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. |
Countries
United States
Outcome results
None listed