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Device

AcumenTM HPI Software Feature for Noncardiac Surgery

N/A

Waitlist Available

Research Sponsored by Edwards Lifesciences

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from post non-cardiac surgery to 30 days.

Awards & highlights

Study Summary

This trial looked at whether a protocolized strategy using Hypotension Prediction Index (HPI) software guidance during surgery could help manage intraoperative hemodynamic better in moderate to high-risk surgeries.

Eligible Conditions

Moderate to High-risk Noncardiac Surgery

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from post non-cardiac surgery to 30 days.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from post non-cardiac surgery to 30 days.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from post non-cardiac surgery to 30 days. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

A Composite of 30-day Moderate-to-severe Perfusion Related Postoperative Complications.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: HPI ArmExperimental Treatment1 Intervention

AcumenTM HPI Software Feature to guide hemodynamic management in moderate-to-high-risk noncardiac surgery.

Group II: Non-HPI armPlacebo Group1 Intervention

Non-protocolized standard of care management per clinician and provider judgement

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Edwards LifesciencesLead Sponsor

180 Previous Clinical Trials

61,167 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the current cohort size for this research project?

"To conduct the trial, Edwards Lifesciences requires 1486 patients that meet their standards for eligibility. The study will be conducted at two major medical centres located in Winston-Salem and Boston respectively."

Answered by AI

Are there several healthcare centers trialing this approach in the city?

"Participants can enroll in this clinical trial at Wake Forest Baptist Medical Center, located in Winston-Salem (North carolina), Massachusetts General Hospital (Boston, MA) and Michigan Medical Health System (Ann Arbor). Additionally, there are 10 other participating sites."

Answered by AI

Are there currently any open slots within this clinical trial?

"Per the clinicaltrials.gov webpage, this research is actively seeking volunteers as of today. It was initially posted on November 17th 2021 and most recently revised on May 23rd 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Hypotension Prediction Index (HPI) SMART-BP Trial

2021. "Hypotension Prediction Index (HPI) SMART-BP Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05105477.