MedTrace Logo

"Hypotension Probability Indicator" in TAVI/MitraClip for Hypotension Management

NCT06347211 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2025-01-14

No results posted yet for this study

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.

Conditions

  • Hypotension During Surgery
  • Prevention of Hypotension

Interventions

DEVICE

Acumen IQ sensor with Hemosphere monitor incorporating the HPI algorithm

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.

Sponsors & Collaborators

  • Attikon Hospital

    lead OTHER

Principal Investigators

  • Tatiana Sidiropoulou, MD,PhD · Attikon Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-10
Primary Completion
2024-12-10
Completion
2024-12-10

Countries

  • Greece

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06347211 on ClinicalTrials.gov