NCT04972266CompletedNot Applicable
European Hypotension Prediction Index Real World Experience Using AcumenTM Hypotension Prediction Index Software to Prevent Intraoperative Hypotension: the Multicentre Prospective Observational Registry
Edwards Lifesciences12 sites in 5 countries702 target enrollmentStarted: September 28, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 702
- Locations
- 12
- Primary Endpoint
- To describe the time-weighted average (TWA) mean arterial pressure (MAP) <65 mmHg when using AcumenTM Hypotension Prediction Index software
Study Overview
Brief Summary
European, multicenter, prospective, observational registry in patients undergoing elective major non-cardiac surgery
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Consenting adult patients (≥18 years)
- •Patient is scheduled for elective major non-cardiac surgery under general anesthesia that is expected to last at least 120 minutes and in whom blood pressure is monitored using an arterial catheter
- •Patients in whom the AcumenTM Hypotension Prediction Index software with the Acumen IQ sensor on the Hemosphere platform is used intraoperatively
Exclusion Criteria
- •Patients undergoing emergency surgery OR nephrectomy, liver and/or kidney transplantation
- •Patients suffering from atrial fibrillation and/or sepsis (according to current Sepsis-3 definition)
- •American Society of Anesthesiology (ASA) physical status classification V or VI
- •Disability and/or other circumstances under which the patient is not able to understand the nature, significance and scope of the investigation
- •Pregnancy at the time of surgery
- •Patients without signed informed consent / data protection statement
- •Patient participating in other interventional trials
Outcomes
Primary Outcomes
To describe the time-weighted average (TWA) mean arterial pressure (MAP) <65 mmHg when using AcumenTM Hypotension Prediction Index software
Time Frame: Duration of the procedure through 30 days after procedure
To describe the time-weighted average (TWA) mean arterial pressure (MAP) \<65 mmHg when using AcumenTM Hypotension Prediction Index software
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (12)
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