Hypotension Prediction Index for Blood Pressure Management (HPI)

NeuroTherapia, Inc.

Status

Completed

Conditions

Intraoperative Hypotension

Treatments

Device: Control

Device: Acumen HPI-enabled EV1000 screen

Study type

Interventional

Funder types

Other

Identifiers

NCT03610165

18-557

Details and patient eligibility

About

Design: Single-center randomized comparison of invasive arterial pressure monitoring vs. arterial pressure monitoring combined with Acumen Hypotension Prediction Index (HPI) software guidance on intraoperative hypotension duration and severity.

Aim: To determine whether use of Acumen HPI software guidance to guide intraoperative hemodynamic management in the non-cardiac surgery reduces the duration and severity of hypotension.

Primary hypothesis: Our primary hypothesis is that adding Acumen HPI software guidance to the information provided by the invasive arterial pressure monitoring during moderate- to high-risk noncardiac surgery reduces time-weighted average (TWA) intraoperative hypotension below a threshold of 65 mmHg.

Full description

STUDY RATIONALE Even when clinicians try to prevent intraoperative hypotension, they often fail because it is difficult to predict which patients will become hypotensive, much less when. A risk score for predicting minute-by-minute intraoperative hypotension is not currently available. Yet it seems likely that ability to identify when a patient is likely to become hypotensive, and the pathophysiology of the event, will improve hemodynamic management and perhaps patient outcome. Acumen HPI appears to be a reliable predictor of intraoperative hypotension, and should thus help clinicians anticipate and avoid hypotension. Furthermore, the secondary guidance provided by the Acumen HPI may help clinicians optimally manage fluids and thus prevent future episodes in the same patient.

AIMS To determine whether use of Acumen HPI software to guide intraoperative hemodynamic management in the non-cardiac surgery reduces the duration and severity of hypotension.

PRIMARY HYPOTHESIS Our primary hypothesis is that use of the Acumen HPI software guidance reduces TWA intraoperative hypotension below a threshold of 65 mmHg.

Specifically, we will compare the amount of intraoperative hypotension below mean-arterial pressure (MAP) threshold of 65 mmHg, in patients randomized to invasive arterial pressure monitoring vs. invasive arterial pressure monitoring with Acumen Hypotension Prediction Index software. In both cases, clinicians will strive to keep MAP above 65 mmHg to the extent practical.

Enrollment

214 patients

Sex

All

Ages

45+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Written informed consent
Age ≥45 years
ASA Physical Status 3 or 4
Moderate- or high-risk surgery (for example, orthopedic, spine, urology, and general surgery)
Planned invasive blood pressure monitoring
General anesthesia
Surgery duration expected to last >2 hours
Planned overnight hospitalization

Exclusion criteria

Contraindication to the invasive blood pressure monitoring
Pregnancy
Emergency surgery
Known clinically important intracardiac shunts
Known aortic stenosis with valve area ≤ 1.5 cm2
Known moderate to severe aortic regurgitation
Known moderate to severe mitral regurgitation
Known moderate to severe mitral stenosis
Patient or surgical procedure type known as an SVV limitation16 (e.g. tidal volume <8mL/kg of theoretical ideal weight, spontaneous ventilation, persistent cardiac arrhythmia, known atrial fibrillation, open chest surgery, Heart Rate/Respiratory Rate (HR/RR) ratio <3.6)
Current persistent atrial fibrillation
Congestive heart failure with ejection fraction <35%
Neurosurgery
Emergent or cardiovascular surgical procedure
Patient who is confirmed to be pregnant
Refusal of patient or authorized representative to sign consent