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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07133126
Acronym
ACUMEN
Enrollment
30
Registered
2025-08-20
Start date
2025-01-01
Completion date
2025-12-01
Last updated
2025-08-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thoracic Surgery or Aortic Vascular Surgery Patients

Keywords

Non-invasive monitoring, thoracic surgery, aortic vascular surgery, HPI system, prediction, hypotension

Brief summary

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.

Interventions

DEVICEAcumen monitoring

Patient undergoing a thoracic surgery or an aortic surgery will be monitored as usual using the CE marked medical device ACUMEN with the intelligent HPI system.

Sponsors

Hospices Civils de Lyon
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

* Adult patients at moderate or high risk (ASA score ≥ 2 and/or Lee score ≥ 2) * scheduled for lung resection by thoracotomy or video-assisted surgery or robotic surgery or fenestrated aortic stenting

Exclusion criteria

* None

Design outcomes

Primary

MeasureTime frameDescription
Impact of ACUMEN monitoringDuring the whole surgeryNumber of episodes of intraoperative arterial hypotension.

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026