NCT04149314

The "Hypotension Prediction Index" in Patients Undergoing Lung Surgery

Completed NA Last updated 1 December 2023

What this trial tests

NA trial testing HPI based hemodynamic optimization algorithm in Hypotension in 142 participants. Completed in 31 October 2023.

Timeline

20 November 2019

Primary endpoint
1 January 2023

31 October 2023

Quick facts

Lead sponsor	University of Giessen
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	treatment
Enrollment	142
Start date	20 November 2019
Primary completion	1 January 2023
Estimated completion	31 October 2023
Sites	1 location across Germany

Drugs / interventions tested

• HPI based hemodynamic optimization algorithm

Conditions studied

• Hypotension — all drugs for Hypotension →
• Hemodynamic Instability — all drugs for Hemodynamic Instability →
• Renal Failure — all drugs for Renal Failure →
• Myocardial Injury — all drugs for Myocardial Injury →

Sponsor

University of Giessen

Who can join

18 and older, any sex, with Hypotension or Hemodynamic Instability. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The "Hypotension Prediction Index (HPI)" was established by the Edwards Lifescience Company (Irvine, California, USA) and is CE certified. As part of the Edwards Acumen Decision-Support-Software-Suite the HPI is supported by the minimal invasive FloTrac Sensor. The HPI displays the probability of an occurring hypotension. The software was established with the help of 20.000 analyzed patient events. If the upper limit of the HPI is reached, the software is alarming the treating physician 8. At the university hospital of Giessen HPI analyses are used in the daily clinical routine as well as for scientific purposes. Preliminary data of the HPI-I-Trial ("Influence of the Hypotension Prediction Index on the number and duration of intraoperative hypotension in primary hip-endoprothetic replacement", University Hospital of Giessen) included patients, which underwent hip-endoprothetic replacement surgery and revealed that the use of HPI with a goal directed therapy (GDT) protocol compared to standard care significantly reduced the incidence and duration of intraoperative hypotension. Therefore HPI with GDT might reduce the incidence of hypotension related complications in a sicker patient cohort.

The aim of the study is to investigate whether a goal directed treatment according to the Hypotension Prediction Index compared to standard care can reduce the incidence of intraoperative hypotension in patients under single lung ventilation.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Surgical data science - from concepts toward clinical translation.
   Maier-Hein L, Eisenmann M, Sarikaya D, März K, et al · · 2022 · cited 158× · PMID 34879287 · DOI 10.1016/j.media.2021.102306