CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 214 enrolled
Drug / intervention
Acumen HPI-enabled EV1000 screen +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03610165
NCT03610165N/ACompleted

The Role of Acumen Hypotension Prediction Index Software in Hypotension Management During Moderate to High-Risk Noncardiac Surgery: A Pilot Randomized Control Trial

The Cleveland Clinic·interventional·Posted Aug 1, 2018·Updated May 19, 2021

In Brief

A clinical study evaluating Acumen HPI-enabled EV1000 screen and Control for Intraoperative Hypotension. Completed, enrolled 214 participants across 1 site.

Detailed Summary

Design: Single-center randomized comparison of invasive arterial pressure monitoring vs. arterial pressure monitoring combined with Acumen Hypotension Prediction Index (HPI) software guidance on intraoperative hypotension duration and severity. Aim: To determine whether use of Acumen HPI software guidance to guide intraoperative hemodynamic management in the non-cardiac surgery reduces the duration and severity of hypotension. Primary hypothesis: Our primary hypothesis is that adding Acumen HPI software guidance to the information provided by the invasive arterial pressure monitoring during moderate- to high-risk noncardiac surgery reduces time-weighted average (TWA) intraoperative hypotension below a threshold of 65 mmHg.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 1, 2018
Enrollment StartJul 12, 2018
Primary CompletionJun 1, 2019
Study CompletionMar 31, 2021
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 7.9 years ago

Interventions

Acumen HPI-enabled EV1000 screendevice

Acumen HPI-enabled EV1000 screen.

Controldevice

Arterial waveform and pressures