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Clinical Trials/NCT07133126
NCT07133126Active, not recruitingNot Applicable

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

Hospices Civils de Lyon1 site in 1 country30 target enrollmentStarted: January 1, 2025Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
30
Locations
1
Primary Endpoint
Impact of ACUMEN monitoring

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

  • Not provided

Outcomes

Primary Outcomes

Impact of ACUMEN monitoring

Time Frame: During the whole surgery

Number of episodes of intraoperative arterial hypotension.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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