Hypotension Prediction Index for Blood Pressure Management

NCT ID: NCT03610165

Last Updated: 2021-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 214 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-12
• Study Completion Date: 2021-03-31

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.

Conditions

Intraoperative Hypotension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Arterial line - Control

Arterial line waveform and pressure

Group Type: PLACEBO_COMPARATOR

Control

Intervention Type: DEVICE

Arterial waveform and pressures

Acumen HPI-enabled EV1000 screen

Arterial line waveform and pressure + HPI alert from EV1000 monitor

Group Type: EXPERIMENTAL

Acumen HPI-enabled EV1000 screen

Intervention Type: DEVICE

Acumen HPI-enabled EV1000 screen.

Interventions

Acumen HPI-enabled EV1000 screen

Acumen HPI-enabled EV1000 screen.

Intervention Type: DEVICE

Control

Arterial waveform and pressures

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Cleveland Clinic

OTHER

Sponsor Role: lead

Responsible Party

Kamal Maheshwari, MD MPH

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kamal Maheshwari, MD, MPH

Role: STUDY_DIRECTOR

The Cleveland Clinic

Locations

Cleveland Clinic

Cleveland, Ohio, United States

Countries

United States

References

Maheshwari K, Shimada T, Fang J, Ince I, Mascha EJ, Turan A, Kurz A, Sessler DI. Hypotension Prediction Index software for management of hypotension during moderate- to high-risk noncardiac surgery: protocol for a randomized trial. Trials. 2019 May 3;20(1):255. doi: 10.1186/s13063-019-3329-0.

Reference Type: DERIVED

PMID: 31053082 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

18-557

Identifier Type: -

Identifier Source: org_study_id