Hypotension Prediction Index Study (HPI Study)
Prospective, Single-Arm, Open-Label, Multicenter Study of Hypotension Prevention and Treatment in Patients Receiving Arterial Pressure Monitoring with Acumen™ Hypotension Prediction Index Feature Software
1 other identifier
observational
485
1 country
11
Brief Summary
A prospective, single-arm, open-label, multicenter post-approval study to determine whether the use of the Acumen HPI Software to guide intraoperative hemodynamic management in non-cardiac surgery reduces the duration of intraoperative hypotension below a threshold of Mean Arterial Pressure (MAP)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2019
Shorter than P25 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 14, 2019
CompletedFirst Posted
Study publicly available on registry
January 15, 2019
CompletedStudy Start
First participant enrolled
May 16, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 17, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 17, 2020
CompletedOctober 18, 2024
August 1, 2020
10 months
January 14, 2019
October 16, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Reduction of Intraoperative Hypotension
Duration (t \[min\]) reduction of intraoperative hypotension (defined as MAP \< 65 mmHg for at least 1 minute) as compared with a historic retrospective control group
Duration of Surgery
Secondary Outcomes (1)
Intraoperative Hypotension in Each Subject
Duration of Surgery
Interventions
EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software
Eligibility Criteria
Subjects recruited and enrolled should be classified as American Society of Anesthesiologist (ASA) physical status 3-4 who are scheduled for moderate-to-high-risk non-cardiac surgery and will be receiving pressure monitoring with an arterial line. Potentially qualifying patients will be evaluated during their preoperative anesthesia clinic visits.
You may qualify if:
- Written informed consent;
- Age ≥ 18 years;
- ASA Physical Status 3 or 4;
- Moderate- or high-risk non-cardiac surgery (for example, orthopedic, spine, urology, and general surgery);
- Planned pressure monitoring with an arterial line;
- General anesthesia;
- Surgery duration expected to last ≥ 3 hours from induction;
- Planned overnight hospitalization.
You may not qualify if:
- Participating in another (interventional) study;
- Contraindication to the invasive blood pressure monitoring;
- Patient who is confirmed to be pregnant and/or nursing mothers;
- Emergency surgery;
- Known clinically important intra-cardiac shunts;
- Patient in whom an intraoperative MAP target will be \< 65 mmHg;
- 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 limitation (5) (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;
- Known acute congestive heart failure;
- Craniotomy;
- Surgery duration expected to last \< 3 hours;
- +3 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Stanford Health Care
Stanford, California, 94305, United States
UCHealth University of Colorado Hospital
Aurora, Colorado, 80045, United States
Yale University
New Haven, Connecticut, 06510, United States
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Columbia University Medical Center
New York, New York, 10032, United States
Cleveland Clinic
Cleveland, Ohio, 97239, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Hospital of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
Bao X, Kumar SS, Shah NJ, Penning D, Weinstein M, Malhotra G, Rose S, Drover D, Pennington MW, Domino K, Meng L, Treggiari M, Clavijo C, Wagener G, Chitilian H, Maheshwari K; HPI Study Team. AcumenTM hypotension prediction index guidance for prevention and treatment of hypotension in noncardiac surgery: a prospective, single-arm, multicenter trial. Perioper Med (Lond). 2024 Mar 4;13(1):13. doi: 10.1186/s13741-024-00369-9.
PMID: 38439069DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Tina Abdelnour, MS, BSN
Edwards Lifesciences
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 14, 2019
First Posted
January 15, 2019
Study Start
May 16, 2019
Primary Completion
March 17, 2020
Study Completion
March 17, 2020
Last Updated
October 18, 2024
Record last verified: 2020-08
Data Sharing
- IPD Sharing
- Will not share