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

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)

Study Overview

• Status: Unknown
• Conditions: Hypotension
• Intervention / Treatment: Device: EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software

• Study Type: Observational
• Enrollment (Actual): 485

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford Health Care
  • Colorado
    • Aurora, Colorado, United States, 80045
      • UCHealth University of Colorado Hospital
  • Connecticut
    • New Haven, Connecticut, United States, 06510
      • Yale University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Ann Arbor, Michigan, United States, 48109
      • University of Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Health System
  • New York
    • New York, New York, United States, 10032
      • Columbia University Medical Center
  • Ohio
    • Cleveland, Ohio, United States, 97239
      • Cleveland Clinic
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Hospital of the University of Pennsylvania
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

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.

Description

Inclusion Criteria:

1. Written informed consent;
2. Age ≥ 18 years;
3. ASA Physical Status 3 or 4;
4. Moderate- or high-risk non-cardiac surgery (for example, orthopedic, spine, urology, and general surgery);
5. Planned pressure monitoring with an arterial line;
6. General anesthesia;
7. Surgery duration expected to last ≥ 3 hours from induction;
8. Planned overnight hospitalization.

Exclusion Criteria:

1. Participating in another (interventional) study;
2. Contraindication to the invasive blood pressure monitoring;
3. Patient who is confirmed to be pregnant and/or nursing mothers;
4. Emergency surgery;
5. Known clinically important intra-cardiac shunts;
6. Patient in whom an intraoperative MAP target will be < 65 mmHg;
7. Known aortic stenosis with valve area ≤ 1.5 cm2;
8. Known moderate to severe aortic regurgitation;
9. Known moderate to severe mitral regurgitation;
10. Known moderate to severe mitral stenosis;
11. 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);
12. Current persistent atrial fibrillation;
13. Known acute congestive heart failure;
14. Craniotomy;
15. Surgery duration expected to last < 3 hours;
16. Burn surgeries;
17. Patients with an intra-aortic balloon pump (IABP) or ventricular assist device(s);
18. Patient transfer from ICU requiring multiple vasoactive agents and known diagnosis of ongoing active sepsis.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Hypotension in Each Subject	The determination of total area under the curve (time and MAP) for Intraoperative Hypotension in each subject. This endpoint is correlated with the duration and a descriptive analysis of this endpoint will be presented with the mean, standard deviation, median, minimum and maximum.	Duration of Surgery

Collaborators and Investigators

• Sponsor: Edwards Lifesciences

Study record dates

Study Major Dates

• Study Start (Actual): May 16, 2019
• Primary Completion (Anticipated): November 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 14, 2019
• First Submitted That Met QC Criteria: January 14, 2019
• First Posted (Actual): January 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: August 3, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypotension
• Other Study ID Numbers: 2018-15

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes