CompletedNot Applicable

Hypotension Prediction Index for Blood Pressure Management

United States214 participantsStarted 2018-07-12

Plain-language 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.

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time- Weighted Average (TWA) MAP Under a Threshold of 65 mmHg.

Timeframe: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).

Hypotension Severity (AUC-MAP) Under a Threshold of 65.

Timeframe: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery) .

Duration of MAP Under a Threshold of 65 mmHg.

Timeframe: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).

Trial details

NCT IDNCT03610165

SponsorThe Cleveland Clinic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-06-01

Results submitted2020-12-15

View on ClinicalTrials.gov More Intraoperative Hypotension trials

Plain-language summary

Who can participate

Age range

45 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Time- Weighted Average (TWA) MAP Under a Threshold of 65 mmHg.

Timeframe: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).

Hypotension Severity (AUC-MAP) Under a Threshold of 65.

Timeframe: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery) .

Duration of MAP Under a Threshold of 65 mmHg.

Timeframe: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).