Clinical trial NCT03610165: Hypotension Prediction Index for Blood Pressure Management
Official title: The Role of Acumen Hypotension Prediction Index Software in Hypotension Management During Moderate to High-Risk Noncardiac Surgery: A Pilot Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Intraoperative Hypotension
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2018-08-01
Enrollment: 214
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: 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).
measure: 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) .
measure: 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).
Secondary outcomes:
measure: Time-weighted Average MAP Below a Threshold of 60 mmHg Per Case
timeFrame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
measure: Time-weighted Average MAP Below a Threshold of 55 mmHg Per Case
timeFrame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
measure: Hypotension Severity (AUC-MAP) Under a Threshold of 60 mmHg.
timeFrame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
measure: Hypotension Severity (AUC-MAP) Under a Threshold of 55 mmHg.
timeFrame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
measure: Duration of MAP Under a Threshold of 60 mmHg.
timeFrame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
measure: Duration of MAP Under a Threshold of 55 mmHg.
timeFrame: MAP measurements were recorded every 20 s by the EV1000 system from induction (start anesthesia) to leaving Operation room (end of surgery).
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Kamal Maheshwari, MD, MPH
role: STUDY_DIRECTOR
References:
citation: 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.