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

NCT ID: NCT07133126

Last Updated: 2025-08-20

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 30 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-01
• Study Completion Date: 2025-12-01

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.

Conditions

Thoracic Surgery or Aortic Vascular Surgery Patients

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Monitored patients

Patient undergoing a thoracic surgery or an aortic surgery will be need to be monitored during and after surgery monitored. We need to predicts and anticipates the occurrence of intraoperative arterial hypotension episodes and enables an advanced, individualized hemodynamic monitoring strategy

Acumen monitoring

Intervention Type: DEVICE

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.

Interventions

Acumen 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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hopital Louis PRADEL Hospices Civils de Lyon

Bron, France, France

Countries

France

Other Identifiers

24-5523

Identifier Type: -

Identifier Source: org_study_id