CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 100 enrolled
Drug / intervention
Acumen IQ sensor with Hemosphere monitor incorporating the HPI algorithmdevice
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/NCT06347211
NCT06347211N/ACompleted

Is the Hypotension Probability Indicator with Goal Directed Haemodynamic Treatment Useful in Predicting and Treating Hypotension in Patients Undergoing Transcatheter Aortic Valve Implantation(TAVI) or MitraClip

Attikon Hospital·interventional·Posted Apr 4, 2024·Updated Jan 14, 2025

In Brief

A clinical study evaluating Acumen IQ sensor with Hemosphere monitor incorporating the HPI algorithm for Hypotension During Surgery and Prevention of Hypotension. Completed, enrolled 100 participants across 1 site.

Detailed Summary

The study will investigate whether the use of Goal Directed Hemodynamic Therapy implemented with the HPI algorithm using a treatment algorithm will reduce the incidence of hypotension and improve treatment of hypotension.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGreece
Collaborators--

Timeline

N/ACompletedFinished
202420252026
First PostedApr 4, 2024
Enrollment StartJan 10, 2024
Primary CompletionDec 10, 2024
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 2.2 years ago

Interventions

Acumen IQ sensor with Hemosphere monitor incorporating the HPI algorithmdevice

Hemosphere monitoring and requires the use of a AcumenIQ sensor connected to an arterial line (Edwards Lifesciences Corp., Irvine, CA, USA). The sensor has a splitter which enables the splitting of the arterial blood pressure signal to facilitate a blood pressure signal on both the anesthesia machine monitor (standard care) and the HemoSphere monitor (study). In the intervention arm we asked the anesthesiologist and anesthesia nurse to use the study treatment flowchart. If the HPI alarm goes off, which entails both a sound and a flickering light, we ask the anesthesiologist to act upon this alarm immediately. Use of the study treatment flowchart ensures that the anesthesiologist has to think about the underlying cause. The HemoSphere with HPI software has a second screen with variables that provide information about the underlying cause of the predicted hypotension.