Hypotension Prediction Index for Blood Pressure Management

Not Applicable

Completed

Conditions: Intraoperative Hypotension

Interventions: Device: Control
Device: Acumen HPI-enabled EV1000 screen

Registration Number: NCT03610165

Lead Sponsor: The Cleveland Clinic

Brief Summary: 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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 214

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arterial line - Control	Control	Arterial line waveform and pressure
Acumen HPI-enabled EV1000 screen	Acumen HPI-enabled EV1000 screen	Arterial line waveform and pressure + HPI alert from EV1000 monitor

Primary Outcome Measures

Name	Time	Method
Time- Weighted Average (TWA) MAP Under a Threshold of 65 mmHg.	MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).	MAP stands for mean arterial pressure. Time-weighted average MAP below 65 mmHg threshold for each patient was derived by dividing AUC-MAP by the time interval between the first and the last MAP measurements.
Hypotension Severity (AUC-MAP) Under a Threshold of 65.	MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery) .	MAP stands for mean arterial pressure; Calculation of a specific area started when MAP was less than 65 mmHg and ended when MAP was greater than 65 mmHg; Hypotension severity (AUC-MAP) below the threshold of 65 mmHg was calculated as the cumulative sum of the areas below the given threshold for a patient using the trapezoid rule and measured in units of mmHg times minutes.
Duration of MAP Under a Threshold of 65 mmHg.	MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).	MAP stands for mean arterial pressure; Duration is the total amount of time (in minutes) that the MAP under a threshold of 65 mmHg

Secondary Outcome Measures

Name	Time	Method
Time-weighted Average MAP Below a Threshold of 60 mmHg Per Case	MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).	MAP stands for mean arterial pressure. Time-weighted average MAP below 60 mmHg threshold for each patient was derived by dividing AUC-MAP by the time interval between the first and the last MAP measurements.
Time-weighted Average MAP Below a Threshold of 55 mmHg Per Case	MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).	MAP stands for mean arterial pressure. Time-weighted average MAP below 55 mmHg threshold for each patient was derived by dividing AUC-MAP by the time interval between the first and the last MAP measurements.
Hypotension Severity (AUC-MAP) Under a Threshold of 60 mmHg.	MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).	MAP stands for mean arterial pressure; Calculation of a specific area started when MAP was less than 60 mmHg and ended when MAP was greater than 60 mmHg. Hypotension severity (AUC-MAP) below the threshold of 60 mmHg was calculated as the cumulative sum of the areas below the given threshold for a patient using the trapezoid rule and measured in units of mmHg times minutes.
Hypotension Severity (AUC-MAP) Under a Threshold of 55 mmHg.	MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).	MAP stands for mean arterial pressure; Calculation of a specific area started when MAP was less than 55 mmHg and ended when MAP was greater than 55 mmHg. Hypotension severity (AUC-MAP) below the threshold of 55 mmHg was calculated as the cumulative sum of the areas below the given threshold for a patient using the trapezoid rule and measured in units of mmHg times minutes.
Duration of MAP Under a Threshold of 60 mmHg.	MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).	MAP stands for mean arterial pressure; Duration is the total amount of time (in minutes) that the MAP under a threshold of 60 mmHg
Duration of MAP Under a Threshold of 55 mmHg.	MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).	MAP stands for mean arterial pressure; Duration is the total amount of time (in minutes) that the MAP under a threshold of 55 mmHg.