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 range45 Years

SexALL

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

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 range45 Years

SexALL

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).