Hypotension Prediction Index Study (HPI Study)

Completed

• Conditions: Hypotension

• Registration Number: NCT03805217
• Lead Sponsor: Edwards Lifesciences

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-14
• Study First Submitted QC: 2019-01-14
• Study First Posted: 2019-01-15
• Study Start: 2019-05-16
• Primary Completion: 2020-03-17
• Study Completion: 2020-03-17
• Status Verified: 2020-08
• Last Update Submitted: 2024-10-16
• Last Update Posted: 2024-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 485

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of Intraoperative Hypotension	Duration of Surgery	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

Secondary Outcome Measures

Name	Time	Method
Intraoperative Hypotension in Each Subject	Duration of Surgery	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.

Trial Locations

Locations (11)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

Stanford Health Care; 🇺🇸 Stanford, California, United States

University of Michigan; 🇺🇸 Ann Arbor, Michigan, United States

UCHealth University of Colorado Hospital; 🇺🇸 Aurora, Colorado, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Henry Ford Health System; 🇺🇸 Detroit, Michigan, United States

Hospital of the University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States

Oregon Health & Science University; 🇺🇸 Portland, Oregon, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Yale University; 🇺🇸 New Haven, Connecticut, United States