Clinical trial NCT03805217: Hypotension Prediction Index Study (HPI Study)
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypotension
Lead sponsor: Edwards Lifesciences
Sponsor class: INDUSTRY
First posted: 2019-01-15
Enrollment: 485
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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)


Eligibility criteria: 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.

Primary outcomes:
measure: Reduction of Intraoperative Hypotension
timeFrame: Duration of Surgery
Secondary outcomes:
measure: Intraoperative Hypotension in Each Subject
timeFrame: Duration of Surgery
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford Health Care
state: California
city: Aurora
country: United States
facility: UCHealth University of Colorado Hospital
state: Colorado
city: New Haven
country: United States
facility: Yale University
state: Connecticut
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Ann Arbor
country: United States
facility: University of Michigan
state: Michigan
city: Detroit
country: United States
facility: Henry Ford Health System
state: Michigan
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Hospital of the University of Pennsylvania
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: Edwards Lifesciences
name: Tina Abdelnour, MS, BSN
role: STUDY_DIRECTOR
References: