N/A N=214 Randomized Double-blind Prevention

Hypotension Prediction Index for Blood Pressure Management

Intraoperative Hypotension

Bottom Line

View on ClinicalTrials.gov: NCT03610165 ↗

Enrolled (actual)

214

Serious AEs

0.0%

Results posted

Feb 2021

Primary outcome: Primary: Time- Weighted Average (TWA) MAP Under a Threshold of 65 mmHg. — 0.14; 0.14 mmHg — p=0.757

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Acumen HPI-enabled EV1000 screen (Device); Control (Device)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: The Cleveland Clinic
Primary completion: Jun 2019

Outcome Measures

Outcome	Result	p-value
PRIMARY Time- Weighted Average (TWA) MAP Under a Threshold of 65 mmHg.	0.14; 0.14	0.757
PRIMARY Hypotension Severity (AUC-MAP) Under a Threshold of 65.	34.2; 32.7	0.715
PRIMARY Duration of MAP Under a Threshold of 65 mmHg.	9.3; 7.7	0.328
SECONDARY Time-weighted Average MAP Below a Threshold of 60 mmHg Per Case	0.02; 0.03	0.376
SECONDARY Time-weighted Average MAP Below a Threshold of 55 mmHg Per Case	0; 0	0.226
SECONDARY Hypotension Severity (AUC-MAP) Under a Threshold of 60 mmHg.	5.3; 6.0	0.610
SECONDARY Hypotension Severity (AUC-MAP) Under a Threshold of 55 mmHg.	0.17; 1.00	0.302
SECONDARY Duration of MAP Under a Threshold of 60 mmHg.	2.0; 2.0	0.889
SECONDARY Duration of MAP Under a Threshold of 55 mmHg.	0.17; 0.67	0.403

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.

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03610165). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.