CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 99 enrolled
Drug / intervention
Flotraq Sensor with EV1000 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/NCT04803903
NCT04803903N/ACompleted

Is The Hypotension Probability Indicator With Goal Directed Haemodynamic Treatment Useful In Predicting And Treating Hypotension In General Anesthesia Patients?

Attikon Hospital·observational·Posted Mar 18, 2021·Updated Jul 30, 2021

In Brief

An observational study evaluating Flotraq Sensor with EV1000 incorporating the HPI algorithm for Hypotension During Surgery. Completed, enrolled 99 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 Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesGreece
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedMar 18, 2021
Enrollment StartNov 5, 2018
Primary CompletionMar 30, 2021
Study CompletionMay 20, 2021
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.3 years ago

Interventions

Flotraq Sensor with EV1000 incorporating the HPI algorithmdevice

The HPI algorithm is only available on the EV1000, Hemosphere and Flotrac monitoring systems and requires the use of a Flotrac sensor connected to an arterial line (Edwards Lifesciences Corp., Irvine, CA, USA). The Flotrac 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 immedietaly. Use of the study treatment flowchart ensures that the anesthesiologist has to think about the underlying cause. The HemoSphere/EV1000 with HPI software has a second screen with variables that provide information about the underlying cause of the predicted hypotension.