Hypotension Prediction Index Study (HPI Study)

Hypotension Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03805217
• Other study ID #: 2018-15
• Status: Active, not recruiting
• Start date: May 16, 2019
• Est. completion date: December 2020

Study information

• Verified date: August 2020
• Source: Edwards Lifesciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 485
• Est. completion date: December 2020
• Est. primary completion date: November 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hypotension

Intervention

Device:
• EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software
EV1000A Clinical Platform with Acumen Hypotension Prediction Index Feature Software

Locations

Country	Name	City	State
United States	University of Michigan	Ann Arbor	Michigan
United States	UCHealth University of Colorado Hospital	Aurora	Colorado
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Cleveland Clinic	Cleveland	Ohio
United States	Henry Ford Health System	Detroit	Michigan
United States	Yale University	New Haven	Connecticut
United States	Columbia University Medical Center	New York	New York
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	Stanford Health Care	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Edwards Lifesciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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