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NCT07133126: ACUMEN

Prediction of Arterial Hypotension by HPI: a Feasibility Study in Lung Resection Surgery and During Fenestrated Aortic Stenting Under General Anesthesia

Active, enrolled Last updated 20 August 2025
What this trial tests

trial testing Acumen monitoring in Thoracic Surgery or Aortic Vascular Surgery Patients in 30 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline
1 January 2025
Primary endpoint
1 April 2025
1 December 2025

Quick facts

Lead sponsorHospices Civils de Lyon
StatusActive, enrolled
Study typeOBSERVATIONAL
Enrollment30
Start date1 January 2025
Primary completion1 April 2025
Estimated completion1 December 2025
Sites1 location across France

Drugs / interventions tested

Conditions studied

Sponsor

Hospices Civils de Lyon — full company profile →

Who can join

18 and older, any sex, with Thoracic Surgery or Aortic Vascular Surgery Patients. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Background: Brief review (literature data, pathology, field of study) Thoracic lung resection surgery has specific imperatives (opening of the thorax, unipulmonary ventilation, lateral decubitus operating position) that challenge the accuracy and precision of hemodynamic monitoring tools in general \[1\] and of systems based on arterial pressure wave analysis in particular. The ACUMEN ClearSight® medical device enhanced by the HPI algorithm, CE marked in 2023, was developed and marketed by Edwards LifeSciences. It has been the subject of some twenty medical scientific publications since 2018 \[2,3\]. It is a non-invasive, single-patient sensor-type device that predicts and anticipates the occurrence of intraoperative arterial hypotension episodes and enables an advanced, individualized hemodynamic monitoring strategy. The prediction of intraoperative arterial hypotension by the HPI machine learning algorithm is based on the invasive or non-invasive analysis of the physiological properties of the arterial pressure wave. The device is designed to optimize blood pressure management during lung resection surgery for cancer or fenestrated thoracic aortic stenting under general anesthesia. It should also enable personalized hemodynamic optimization of vascular filling and intraoperative management of vasopressor agents in patients at cardiac risk, leading ultimately to a reduction in hospital morbidity and mortality. Non-invasive monitoring with the ClearSight® system is used routinely in the operating room at Hôpital Louis Pradel, but without the intelligent HPI system.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other Hospices Civils de Lyon trials

Trials by the same sponsor.

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Data sources for this page

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