Hypotension Prediction Index for Blood Pressure Management

Completed · Not applicable

Conditions studied: Intraoperative Hypotension

In brief

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.

Key facts

Study ID

NCT03610165

Run by

The Cleveland Clinic

People needed

214

Starts

2018-07-12

Expected to finish

2021-03-31

Last updated by the study team

2021-05-19

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Cleveland Clinic — Cleveland, Ohio, United States

Full record on ClinicalTrials.gov

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